Novel Device to Assess Endotracheal Tube Migration

Novel Device (AirWave™) 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.

Study Overview

• Status: Completed
• Conditions: Mechanically Ventilated Patients Admitted to a MICU
• Intervention / Treatment: Other: AirWave

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MICU Based

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: AirWave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Adriano Tonelli, MD, The Cleveland Clinic Foundatin

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimated): October 2, 2012

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 111128-PIP