Novel Device to Assess Endotracheal Tube Migration

NCT ID: NCT01697215

Last Updated: 2025-05-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Mechanically Ventilated Patients Admitted to a MICU

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

AirWave

Intervention Type OTHER

Interventions

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AirWave

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Adriano Tonelli

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriano Tonelli, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic Foundatin

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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111128-PIP

Identifier Type: -

Identifier Source: org_study_id

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