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OpenTrials
Completed

NCT Number: NCT01697215

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.

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Key information

Conditions

Mechanically Ventilated Patients Admitted to a MICU

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AirWave

Other

Primary outcomes

  1. Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR

    Time frame: 24 hours

    Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Novel Device (AirWave™) to Assess Endotracheal Tube Migration.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 2, 2012
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.