N/A
N=42
Novel Device to Assess Endotracheal Tube Migration
Mechanically Ventilated Patients Admitted to a MICU
Bottom Line
View on ClinicalTrials.gov: NCT01697215 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR — -0.06; -0.29; 0.39 cm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AirWave (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR |
-0.06; -0.29; 0.39 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01697215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.