Novel Device to Assess Endotracheal Tube Migration
This study has been completed.
Information provided by (Responsible Party):
Adriano Tonelli, The Cleveland Clinic
First received: September 21, 2012
Last updated: September 28, 2012
Last verified: September 2012
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Novel Device (AirWave™) to Assess Endotracheal Tube Migration.
Primary Outcome Measures:
- 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:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Subjects ventilated through a tracheostomy
- Subjects under 18 years of age
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01697215
|Cleveland, Ohio, United States, 44195 |
The Cleveland Clinic
ClinicalTrials.gov processed this record on April 27, 2016
||Adriano Tonelli, Staff Physician, The Cleveland Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 21, 2012
||September 28, 2012
||United States: Institutional Review Board