Atelectasis, Pulmonary Complications
Conditions
Brief summary
To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.
Detailed description
Post-operative pulmonary complications (PPC) are associated with significant excess morbidity, mortality and healthcare expenditure. Although PPCs are an incompletely understood multifactorial syndrome, atelectasis is recognized as a critical component. A variety of strategies have been shown to reduce the risk for development of post-operative atelectasis including lung expansion (LE) therapies. Well-designed studies are needed to distinguish which LE approach has the greatest potential to optimize patient care, clinical outcomes and cost savings. Intrapulmonary percussive ventilation (IPV) devices have been in use for more than 25 years and are used widely in the acute care, post-surgical, and homecare setting. Such devices provide both LE and airway clearance therapy (ACT) for patients with obstructive and/or restrictive lung diseases and conditions. The MetaNeb® System is an LE expansion modality that incorporates all the physiological effects of IPV while providing additional therapeutic advantages intended primarily to more effectively treat or prevent pulmonary atelectasis. The study was be conducted in two stages. In Stage I of the study, a retrospective review of medical records for post-surgical patients, who received STANDARD THERAPY as defined by current hospital and respiratory care department policies and procedures was performed. In Stage II, a CHANGE IN PRACTICE was made and patients received standard care with the addition of therapy with The MetaNeb® System. Demographic, clinical & outcome data was collected for eligible patients during the two stages of the study. Study staff collected data from the medical records, following a protocol determined schedule.
Interventions
DEVICEMetaNeb® System
The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study will be that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patients respiratory care regimen will remain the same as during the standard therapy period, however the CHANGE IN PRACTICE will incorporate the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System will follow the labeling of the device.
Sponsors
Hill-Rom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Post-thoracic, -upper abdominal or -aortic surgery Open surgical procedure Incision at or above the umbilicus High risk defined by: Documented ASA class ≥ 3 OR Documented ASA class 2 AND One or more of the following: Current smoker or smoking history within past 6 months History of COPD Documented obesity and/or BMI ≥ 30 kg/m2 Age ≥ 75
Exclusion criteria
Contraindication to Continuous High Frequency Oscillation (CHFO) therapy Minimally invasive, or . . . scopic procedure. Spinal surgery involving a posterior approach. Surgery for organ transplant. Chronic invasive positive pressure ventilation (PPV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant Postoperative Pulmonary Complication Incidence. | Within seven (7) days of the post-surgical admission | One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC) * Patient requires prolonged mechanical ventilation (\> 24 hours from post-surgical admission) * Patient requires prolonged respiratory support for \> 24 hours from post-surgical admission * Diagnosis of pneumonia within seven (7) days * Readmission to ICU for pulmonary complications within seven (7) days of post-surgical hospital admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission) | Respiratory support greater than the patient's baseline level for a period longer than 48 hours * Requirement for non-invasive ventilation (NIV) above patient's baseline requirement after hour 48 from post-surgical admission or continuous positive airway pressure (CPAP) above patient's baseline requirement after hour 48. * Requirement for O2 therapy \> 40 % FiO2 or \> 5 LPM pm via Nasal Cannula (and above patient's baseline) after hour 48 postoperatively. |
| Length of ICU Stay During Initial Hospital Stay | Total days/hours until time of discharge from the hospital, up to 8 weeks | ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented: * Time of admission to the ICU to actual time of initial discharge from the ICU during initial hospital stay * Total ICU days/hours (includes readmissions) during initial hospital stay |
| Length of Hospital Stay During Initial Hospital Stay | Time of admission until time of discharge from the hospital, up to 8 weeks | Hospital length of stay was determined by calculating the number of days/hours spent in hospital. The following was documented: • Time of admission to time of discharge from the hospital (total days/hours) |
| Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission) | Defined as patient requirement for invasive mechanical ventilation (MV) for \> 48 hours (after hour 48) post-operatively. This includes patients that require re-intubation after hour 48, regardless of length of time on MV in the first 48 hours postoperatively. |
| Readmission to Hospital | 30 days following discharge from the hospital | Hospital records were reviewed at each site, 30 days after the last patient has been discharged from the hospital. Readmissions, for any cause, within 30 days of discharge for any study patient were documented. |
| Time on Mechanical Ventilation | total hours/days from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks | * Time to initial extubation from time of initial intubation, if initial intubation was placed after surgery; or from time of post-surgical admission, if intubation was in place prior to start of surgery * Total time on invasive mechanical ventilation - was determined for each patient by calculating the total number of days/hours intubated and mechanically ventilated from the time of post-surgical admission until the time of initial hospital discharge. * Total time on non-invasive ventilation - was determined for each patient by calculating the total number of days/hours ordered for non-invasive ventilation from the time of post-surgical admission to the hospital unit until the time of initial hospital discharge. |
| Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | during hospital stay, up to 8 weeks | Readmissions to ICU and transfers to an elevated level of care, during the initial hospital stay, was documented for each event. The following was documented: * Number of readmission to ICU or elevated level of care events * Number of patients requiring readmission to the ICU or to an elevated level of care |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Therapy - Stage I Retrospectively collected medical records related to respiratory care from patients on STANDARD THERAPY without MetaNeb® as defined by current hospital and Respiratory Care department policies and procedures, was conducted. The purpose of Stage I was to estimate the incidence of postoperative pulmonary complications that occur in postsurgical patients who received standard therapy. | 210 |
| Change in Practice - Stage II Patients who received standard care with the addition of therapy with The MetaNeb® System.
MetaNeb® System: The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study was that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patient's respiratory care regimen remained the same as during the standard therapy period, however the CHANGE IN PRACTICE incorporated the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System followed the labeling of the device. | 209 |
| Total | 419 |
Baseline characteristics
| Characteristic | Standard Therapy - Stage I | Change in Practice - Stage II | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 81 Participants | 96 Participants | 177 Participants |
| Age, Categorical Between 18 and 65 years | 129 Participants | 113 Participants | 242 Participants |
| Age, Continuous | 57.4 Years STANDARD_DEVIATION 15.48 | 61.1 Years STANDARD_DEVIATION 13.72 | 59.24 Years STANDARD_DEVIATION 14.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 203 Participants | 201 Participants | 404 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 29 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) White | 168 Participants | 177 Participants | 345 Participants |
| Sex: Female, Male Female | 95 Participants | 78 Participants | 173 Participants |
| Sex: Female, Male Male | 115 Participants | 131 Participants | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 210 | 7 / 209 |
| other Total, other adverse events | 0 / 210 | 1 / 209 |
| serious Total, serious adverse events | 9 / 210 | 8 / 209 |
Outcome results
Primary
Significant Postoperative Pulmonary Complication Incidence.
One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC) * Patient requires prolonged mechanical ventilation (\> 24 hours from post-surgical admission) * Patient requires prolonged respiratory support for \> 24 hours from post-surgical admission * Diagnosis of pneumonia within seven (7) days * Readmission to ICU for pulmonary complications within seven (7) days of post-surgical hospital admission
Time frame: Within seven (7) days of the post-surgical admission
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Therapy - Stage I | Significant Postoperative Pulmonary Complication Incidence. | Number of subjects without ≥ 1 PPC | 162 Participants |
| Standard Therapy - Stage I | Significant Postoperative Pulmonary Complication Incidence. | Number of subjects with ≥ 1 PPC | 48 Participants |
| Change in Practice - Stage II | Significant Postoperative Pulmonary Complication Incidence. | Number of subjects with ≥ 1 PPC | 33 Participants |
| Change in Practice - Stage II | Significant Postoperative Pulmonary Complication Incidence. | Number of subjects without ≥ 1 PPC | 176 Participants |
Secondary
Length of Hospital Stay During Initial Hospital Stay
Hospital length of stay was determined by calculating the number of days/hours spent in hospital. The following was documented: • Time of admission to time of discharge from the hospital (total days/hours)
Time frame: Time of admission until time of discharge from the hospital, up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Therapy - Stage I | Length of Hospital Stay During Initial Hospital Stay | 8.40 Days | Standard Deviation 7.895 |
| Change in Practice - Stage II | Length of Hospital Stay During Initial Hospital Stay | 6.78 Days | Standard Deviation 4.978 |
Secondary
Length of ICU Stay During Initial Hospital Stay
ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented: * Time of admission to the ICU to actual time of initial discharge from the ICU during initial hospital stay * Total ICU days/hours (includes readmissions) during initial hospital stay
Time frame: Total days/hours until time of discharge from the hospital, up to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Therapy - Stage I | Length of ICU Stay During Initial Hospital Stay | 2.11 Days | Standard Deviation 6.004 |
| Change in Practice - Stage II | Length of ICU Stay During Initial Hospital Stay | 1.27 Days | Standard Deviation 2.672 |
Secondary
Readmission to Hospital
Hospital records were reviewed at each site, 30 days after the last patient has been discharged from the hospital. Readmissions, for any cause, within 30 days of discharge for any study patient were documented.
Time frame: 30 days following discharge from the hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Therapy - Stage I | Readmission to Hospital | 36 Participants |
| Change in Practice - Stage II | Readmission to Hospital | 28 Participants |
Secondary
Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay
Readmissions to ICU and transfers to an elevated level of care, during the initial hospital stay, was documented for each event. The following was documented: * Number of readmission to ICU or elevated level of care events * Number of patients requiring readmission to the ICU or to an elevated level of care
Time frame: during hospital stay, up to 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Therapy - Stage I | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Number of readmissions: None | 205 Participants |
| Standard Therapy - Stage I | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Number of readmissions: Once | 5 Participants |
| Standard Therapy - Stage I | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Number of readmissions: More than Once | 0 Participants |
| Change in Practice - Stage II | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Number of readmissions: Once | 4 Participants |
| Change in Practice - Stage II | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Number of readmissions: None | 204 Participants |
| Change in Practice - Stage II | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Number of readmissions: More than Once | 1 Participants |
Secondary
Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
Defined as patient requirement for invasive mechanical ventilation (MV) for \> 48 hours (after hour 48) post-operatively. This includes patients that require re-intubation after hour 48, regardless of length of time on MV in the first 48 hours postoperatively.
Time frame: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Therapy - Stage I | Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | 19 Participants |
| Change in Practice - Stage II | Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | 14 Participants |
Secondary
Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
Respiratory support greater than the patient's baseline level for a period longer than 48 hours * Requirement for non-invasive ventilation (NIV) above patient's baseline requirement after hour 48 from post-surgical admission or continuous positive airway pressure (CPAP) above patient's baseline requirement after hour 48. * Requirement for O2 therapy \> 40 % FiO2 or \> 5 LPM pm via Nasal Cannula (and above patient's baseline) after hour 48 postoperatively.
Time frame: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Therapy - Stage I | Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | 21 Participants |
| Change in Practice - Stage II | Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | 19 Participants |
Secondary
Time on Mechanical Ventilation
* Time to initial extubation from time of initial intubation, if initial intubation was placed after surgery; or from time of post-surgical admission, if intubation was in place prior to start of surgery * Total time on invasive mechanical ventilation - was determined for each patient by calculating the total number of days/hours intubated and mechanically ventilated from the time of post-surgical admission until the time of initial hospital discharge. * Total time on non-invasive ventilation - was determined for each patient by calculating the total number of days/hours ordered for non-invasive ventilation from the time of post-surgical admission to the hospital unit until the time of initial hospital discharge.
Time frame: total hours/days from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Therapy - Stage I | Time on Mechanical Ventilation | Time to Initial Extubation | 18.57 Hours | Standard Deviation 75.04 |
| Standard Therapy - Stage I | Time on Mechanical Ventilation | Total Time on Invasive Mechanical Ventilation | 23.7 Hours | Standard Deviation 107.47 |
| Standard Therapy - Stage I | Time on Mechanical Ventilation | Total Time on Non-Invasive Mechanical Ventilation | 0.5 Hours | Standard Deviation 4.21 |
| Change in Practice - Stage II | Time on Mechanical Ventilation | Time to Initial Extubation | 7.64 Hours | Standard Deviation 25.02 |
| Change in Practice - Stage II | Time on Mechanical Ventilation | Total Time on Invasive Mechanical Ventilation | 8.5 Hours | Standard Deviation 27.4 |
| Change in Practice - Stage II | Time on Mechanical Ventilation | Total Time on Non-Invasive Mechanical Ventilation | 0.6 Hours | Standard Deviation 3.31 |