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Novel Device to Assess Endotracheal Tube Migration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697215
First Posted: October 2, 2012
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adriano Tonelli, The Cleveland Clinic
  Purpose
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.

Condition Intervention
Mechanically Ventilated Patients Admitted to a MICU Other: AirWave

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Device (AirWave™) to Assess Endotracheal Tube Migration.

Further study details as provided by Adriano Tonelli, The Cleveland Clinic:

Primary Outcome Measures:
  • Endotracheal tube displacement measured by a novel device (AirWave) [ Time Frame: within 24 hours after intubation. ]

    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.



Enrollment: 50
Study Start Date: April 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MICU Based
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697215


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Adriano Tonelli, MD The Cleveland Clinic Foundatin
  More Information

Responsible Party: Adriano Tonelli, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01697215     History of Changes
Other Study ID Numbers: 111128-PIP
First Submitted: September 21, 2012
First Posted: October 2, 2012
Last Update Posted: December 13, 2016
Last Verified: December 2016