Atelectasis
Conditions
Brief summary
To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.
Detailed description
Study Population: Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results. Duration of treatment: Duration of treatment with The MetaNeb® System will be a minimum of 48 hours, or until the subject is discharged from the hospital (if discharge is earlier). Enrolled subjects will remain in the study through Day 4 or until the subject is discharged from the hospital, whichever occurs sooner.
Interventions
DEVICEThe MetaNeb® System
Sponsors
Hill-Rom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-surgical (thoracic, cardiac or abdominal surgery) * Age ≥ 18 years * Significant atelectasis by chest x-ray * Patient meets indication for therapy intervention as defined by Recruitment and Airway Clearance Protocol (Respiratory Department Policy and Procedure) * Signed informed consent
Exclusion criteria
* Cause of atelectasis suspected to be infectious or solid mass * Requirement for mechanical ventilation * Requirement for chronic supplemental oxygen * Hemodynamically unstable, as defined by need for vasopressor therapy * Anticipated need for mechanical ventilation or other poor clinical outcome, unrelated to atelectasis or secretion retention * Contraindication to MetaNeb® therapy (untreated tension pneumothorax) * Inability to perform MetaNeb® therapy using a mouthpiece * Anticipated hospital discharge within 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Approximately 48 hours post-initiation of therapy with The MetaNeb® System. | Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4 | Mean chest x-ray score change for both lungs at Day 1 (approx. 24 hours) and at Day 4 (approx. 96 hours or at discharge, if discharge occurs before Day 4) after initiation of therapy with The MetaNeb® System. Scored using the Kelly score, as described above, to assess the presence of atelectasis. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,) |
| Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Comparing baseline, Day 1, Day 2, and Day 4/discharge. | Chest x-ray improvement using a comparative scale after a minimum of forty-eight (48) hours of therapy with The MetaNeb® System. Chest x-ray improvement assessed using comparative scale for baseline, Day 1, Day 2, and Day 4/discharge. Four chest x-rays for each enrolled subject (baseline, Day 1, Day 2, and day 4/discharge), with date and time masked, were sent to the radiologist for comparison. The radiologist ranked the four x-rays as 1, 2, 3, or 4 (1 = least atelectasis, 4 = most atelectasis). \*Subjects 3 and 4 were discharged on Day 2, and therefore the Day 2 and Day 4/Early Discharge Chest X-rays are one in the same for the purposes of the analysis |
| Oxygenation Index (SpO2 /FiO2 Ratio). | Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge | Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge compared to baseline. SPO2/FiO2 is available for only the 6 subjects that received oxygen during the study. Subjects 3 and 4 did not receive oxygen and no SPO2/FiO2 ratios were calculated. higher SPO2/FiO2 value indicates better oxygenation. |
| Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. | Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2. | Patient reported level of dyspnea (assessed by Modified Borg Dyspnea Scale).This is a scale that asks patients to rate the difficulty of their breathing. It starts at number zero (0) where the breathing is causing the patient no difficulty at all, and progresses through to number ten (10) where the patients' breathing difficulty is maximal. 0: Nothing at all; 0.5: Very, very slight (just noticeable); 1: Very slight; 2: Slight; 3: Moderate; 4: Somewhat severe; 5: Severe; 7: Very severe; 9: Very, very severe (almost maximal); 10: Maximal. |
| Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Respiratory status evaluation at time of enrollment and on Day 2 | Change in patient respiratory status (Respiratory Status Evaluation). Physician observation and evaluation of patient respiratory status at time of enrollment (baseline) and on Day 2 to assess if worse, unchanged, or improved through: * Lung assessment: percussion * Lung assessment: Auscultation * Cough assessment * Secretion assessment * oxygenation * Work of breathing * Other observations: General appearance, mental acuity, respiratory pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The MetaNeb® System Treatment Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment.
The MetaNeb® System | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | The MetaNeb® System Treatment |
|---|---|
| Age, Continuous | 69.6 Years STANDARD_DEVIATION 5.9 |
| BMI | 28.18 kg/m^2 STANDARD_DEVIATION 3.271 |
| Bronchiectasis No | 8 Participants |
| Bronchiectasis Yes | 0 Participants |
| COPD No | 6 Participants |
| COPD Yes | 2 Participants |
| Cystic Fibrosis No | 8 Participants |
| Cystic Fibrosis Yes | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History of Asthma No | 8 Participants |
| History of Asthma Yes | 0 Participants |
| Neuromuscular disease No | 8 Participants |
| Neuromuscular disease Yes | 0 Participants |
| Obstructive Sleep Apnea No | 8 Participants |
| Obstructive Sleep Apnea Yes | 0 Participants |
| Other Pulmonary Condition No | 7 Participants |
| Other Pulmonary Condition Yes | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.
Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,)
Time frame: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 2 : Baseline Score | 1.63 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 2 : Day 2 Score | 1.75 scores on a scale | Standard Deviation 0.35 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 4 : Baseline Score | 1.25 scores on a scale | Standard Deviation 0 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 4 : Day 2 Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 5 : Baseline Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 5 : Day 2 Score | 1.25 scores on a scale | Standard Deviation 0 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 6 : Baseline Score | 0.75 scores on a scale | Standard Deviation 1.06 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 6 : Day 2 Score | 1.25 scores on a scale | Standard Deviation 0.35 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 8 : Baseline Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Subject 8 : Day 2 Score | 0.63 scores on a scale | Standard Deviation 0.88 |
Secondary
Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation.
Change in patient respiratory status (Respiratory Status Evaluation). Physician observation and evaluation of patient respiratory status at time of enrollment (baseline) and on Day 2 to assess if worse, unchanged, or improved through: * Lung assessment: percussion * Lung assessment: Auscultation * Cough assessment * Secretion assessment * oxygenation * Work of breathing * Other observations: General appearance, mental acuity, respiratory pain
Time frame: Respiratory status evaluation at time of enrollment and on Day 2
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Lung Assessment: Percussion | Improved | 7 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Lung Assessment: Percussion | Unchanged | 1 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Lung Assessment: Percussion | Worse | 0 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Lung Assessment: Auscultation | Improved | 7 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Lung Assessment: Auscultation | Unchanged | 1 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Lung Assessment: Auscultation | Worse | 0 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Cough Assessment | Improved | 7 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Cough Assessment | Unchanged | 1 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Cough Assessment | Worse | 0 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Secretion Assessment | Improved | 6 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Secretion Assessment | Unchanged | 2 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Secretion Assessment | Worse | 0 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Oxygenation | Improved | 6 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Oxygenation | Unchanged | 2 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Oxygenation | Worse | 0 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Work of Breathing | Improved | 5 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Work of Breathing | Unchanged | 3 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Work of Breathing | Worse | 0 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Other Observations (General Appearance, Mental Acuity, Respiratory Pain) | Improved | 7 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Other Observations (General Appearance, Mental Acuity, Respiratory Pain) | Unchanged | 1 Participants |
| The MetaNeb® System Treatment | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Other Observations (General Appearance, Mental Acuity, Respiratory Pain) | Worse | 0 Participants |
Secondary
Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline.
Mean chest x-ray score change for both lungs at Day 1 (approx. 24 hours) and at Day 4 (approx. 96 hours or at discharge, if discharge occurs before Day 4) after initiation of therapy with The MetaNeb® System. Scored using the Kelly score, as described above, to assess the presence of atelectasis. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,)
Time frame: Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 8: Day 4/Early Termination Score | 0.63 scores on a scale | Standard Deviation 0.88 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 2: Baseline Score | 1.63 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 2: Day 1 Score | 1.75 scores on a scale | Standard Deviation 0.35 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 2: Day 4/Early Termination Score | 1.25 scores on a scale | Standard Deviation 0 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 4: Baseline Score | 1.25 scores on a scale | Standard Deviation 0 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 4: Day 1 Score | 1.25 scores on a scale | Standard Deviation 0 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 4: Day 4/Early Termination Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 5: Baseline Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 5: Day 1 Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 5: Day 4/Early Termination Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 6: Baseline Score | 0.75 scores on a scale | Standard Deviation 1.06 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 6: Day 1 Score | 1.25 scores on a scale | Standard Deviation 0.35 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 6: Day 4/Early Termination Score | 1.25 scores on a scale | Standard Deviation 0.35 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 8: Baseline Score | 1.13 scores on a scale | Standard Deviation 0.18 |
| The MetaNeb® System Treatment | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Subject 8: Day 1 Score | 1.13 scores on a scale | Standard Deviation 0.18 |
Secondary
Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge).
Chest x-ray improvement using a comparative scale after a minimum of forty-eight (48) hours of therapy with The MetaNeb® System. Chest x-ray improvement assessed using comparative scale for baseline, Day 1, Day 2, and Day 4/discharge. Four chest x-rays for each enrolled subject (baseline, Day 1, Day 2, and day 4/discharge), with date and time masked, were sent to the radiologist for comparison. The radiologist ranked the four x-rays as 1, 2, 3, or 4 (1 = least atelectasis, 4 = most atelectasis). \*Subjects 3 and 4 were discharged on Day 2, and therefore the Day 2 and Day 4/Early Discharge Chest X-rays are one in the same for the purposes of the analysis
Time frame: Comparing baseline, Day 1, Day 2, and Day 4/discharge.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 1 - Baseline | 4 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 1 - Day 1 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 1 - Day 2 | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 1 - Day 4/Early Discharge | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 2 - Baseline | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 2 - Day 1 | 4 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 2 - Day 2 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 2 - Day 4/Early Discharge | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 3 - Baseline | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 3 - Day 1 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 3 - Day 2* | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 3 - Day 4/Early Discharge* | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 4 - Baseline | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 4 - Day 1 | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 4 - Day 2* | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 4 - Day 4/Early Discharge* | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 5 - Baseline | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 5 - Day 1 | 4 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 5 - Day 2 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 5 - Day 4/Early Discharge | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 6 - Baseline | 4 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 7 - Day 4/Early Discharge | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 6 - Day 1 | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 6 - Day 2 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 6 - Day 4/Early Discharge | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 7 - Baseline | 1 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 7 - Day 1 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 7 - Day 2 | 4 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 8 - Baseline | 4 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 8 - Day 1 | 3 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 8 - Day 2 | 2 scores on a scale |
| The MetaNeb® System Treatment | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Subject 8 - Day 4/Early Discharge | 1 scores on a scale |
Secondary
Oxygenation Index (SpO2 /FiO2 Ratio).
Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge compared to baseline. SPO2/FiO2 is available for only the 6 subjects that received oxygen during the study. Subjects 3 and 4 did not receive oxygen and no SPO2/FiO2 ratios were calculated. higher SPO2/FiO2 value indicates better oxygenation.
Time frame: Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 7 - Day 2 PM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 1 - Baseline | 267 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 1 - Day 1 AM | 275 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 1 - Day 1 PM | 275 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 1 - Day 2 AM | 278 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 1 - Day 2 PM | 313 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 1 - Day 4/Early Discharge | 275 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 2 - Baseline | 218 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 2 - Day 1 AM | 291 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 2 - Day 1 PM | 300 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 2 - Day 2 AM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 2 - Day 2 PM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 2 - Day 4/Early Discharge | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 5 - Baseline | 350 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 5 - Day 1 AM | 357 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 5 - Day 1 PM | 336 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 5 - Day 2 AM | 354 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 5 - Day 2 PM | 336 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 5 - Day 4/Early Discharge | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 6 - Baseline | 269 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 6 - Day 1 AM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 6 - Day 1 PM | 346 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 6 - Day 2 AM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 6 - Day 2 PM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 6 - Day 4/Early Discharge | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 7 - Baseline | 309 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 7 - Day 1 AM | 325 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 7 - Day 1 PM | 400 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 7 - Day 2 AM | 400 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 7 - Day 4/Early Discharge | 350 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 8 - Baseline | 350 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 8 - Day 1 AM | 357 SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 8 - Day 1 PM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 8 - Day 2 AM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 8 - Day 2 PM | NA SPO2/FiO2 ratio |
| The MetaNeb® System Treatment | Oxygenation Index (SpO2 /FiO2 Ratio). | Subject 8 - Day 4/Early Discharge | NA SPO2/FiO2 ratio |
Secondary
Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale.
Patient reported level of dyspnea (assessed by Modified Borg Dyspnea Scale).This is a scale that asks patients to rate the difficulty of their breathing. It starts at number zero (0) where the breathing is causing the patient no difficulty at all, and progresses through to number ten (10) where the patients' breathing difficulty is maximal. 0: Nothing at all; 0.5: Very, very slight (just noticeable); 1: Very slight; 2: Slight; 3: Moderate; 4: Somewhat severe; 5: Severe; 7: Very severe; 9: Very, very severe (almost maximal); 10: Maximal.
Time frame: Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The MetaNeb® System Treatment | Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. | Mean Score at Baseline | 3.5 scores on a scale | Standard Deviation 1.31 |
| The MetaNeb® System Treatment | Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. | Mean Score at Day 1 | 3.25 scores on a scale | Standard Deviation 1.58 |
| The MetaNeb® System Treatment | Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. | Mean Score at Day 2 | 1.94 scores on a scale | Standard Deviation 1.15 |