Novel Device to Assess Endotracheal Tube Migration
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.
Mechanically Ventilated Patients Admitted to a Medical Intensive Care Unit.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Novel Device (AirWave™) to Assess Endotracheal Tube Migration.|
- Endotracheal tube displacement measured by a novel device (AirWave) [ Designated as safety issue: No ]
Use of the AirWave in the study group to calculate ETT tip distance from the carina will demonstrate a strong positive correlation with chest x-rays results. Specific endpoints will include:
• Compare CXR tube tip movement/distance to carina measurement results to AirWave tube tip movement/distance to carina calculation results (from the AirWave baseline location) within 24 hours after intubation.
|Study Start Date:||April 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Oral or nasal endotracheal intubation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697215
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|