Mechanically Ventilated Patients Admitted to a MICU
Conditions
Brief summary
To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.
Interventions
OTHERAirWave
Sponsors
The Cleveland Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria: * Oral or nasal endotracheal intubation, anticipated to last at least 48 hours * Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm * Subject must be at least 18 years old (no upper age limitation) * English speaking patients/decision makers.
Exclusion criteria
* Subjects ventilated through a tracheostomy * Subjects under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR | 24 hours | Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis. |
Countries
United States
Participant flow
Recruitment details
During the study period, 42 patients were enrolled. Subjects had the AirWave system placed within 24 hours of endotracheal intubation. A total of 19 patients had measurements of ETT migration at 24 hours by the three methodologies used in this study.
Pre-assignment details
Inclusion Criteria: subjects were eligible for the study if they met all of the following criteria: (1) age \> 18 years old; (2) oral endotracheal intubation within 24 hours of recruitment; (3) expected duration of mechanical ventilation \> 24 hours; (4) ETT internal diameter sizes from 6.5 to 9.0 mm. Exclusion criteria: subjects were excluded from participation if (1) ventilated through a tracheostomy, (2) unable to obtain consent, or (3) pregnancy.
Participants by arm
| Arm | Count |
|---|---|
| (ETT) Migration During Routine Care Among Critically Ill Patients A total of 42 patients (age: 61 \[SD ±13\] years, men: 52%) were recruited. A total of 19 patients had measurements of ETT migration at 24 hours by the 3 methodologies used in this study. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | CXR not available | 9 |
| Overall Study | Malfunction | 9 |
| Overall Study | Physician Decision | 5 |
Baseline characteristics
| Characteristic | (ETT) Migration During Routine Care Among Critically Ill Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 42 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR
Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis.
Time frame: 24 hours
Population: A total of 19 patients had measurements of ETT migration at 24 hours by the three methodologies used in this study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral or Nasal Endotracheal Intubation | Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR | Migration measured by CXR | -0.06 cm | Standard Deviation 1.3 |
| Oral or Nasal Endotracheal Intubation | Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR | Migration measured by EET lip distance | -0.29 cm | Standard Deviation 0.93 |
| Oral or Nasal Endotracheal Intubation | Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR | Migration measured by AirWave System | 0.39 cm | Standard Deviation 1.5 |