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Novel Device to Assess Endotracheal Tube Migration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adriano Tonelli, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01697215
First received: September 21, 2012
Last updated: September 28, 2012
Last verified: September 2012
  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 Medical Intensive Care Unit.
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 The Cleveland Clinic:

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.



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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697215

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Adriano Tonelli, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01697215     History of Changes
Other Study ID Numbers: 111128-PIP
Study First Received: September 21, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014