Novel Device to Assess Endotracheal Tube Migration

Completed

• Conditions: Mechanically Ventilated Patients Admitted to a MICU
• Interventions: Other: AirWave

• Registration Number: NCT01697215
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Results First Submitted: 2023-11-10
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Results First Posted: 2025-05-14
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral or nasal endotracheal intubation	AirWave	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States