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Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube

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.
 
ClinicalTrials.gov Identifier: NCT02787681
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
H. Bryant Nguyen, Loma Linda University

Brief Summary:
The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: NEMO Gauge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube After Intubation of Critically Ill Patients
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Arm Intervention/treatment
Experimental: NEMO Gauge
Measurement and adjustment of endotracheal tube position by stylet.
Device: NEMO Gauge
Measurement and adjustment of endotracheal tube position by stylet.




Primary Outcome Measures :
  1. Percent of correct endotracheal tube position [ Time Frame: Immediate, post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
  2. Patients who have been intubated or at high risk of being intubated, requiring confirmation of ETT position after intubation as determined by the clinical team
  3. Endotracheal tube size 7.0 mm to 8.5 mm in diameter

Exclusion Criteria:

  1. Patients with active hemoptysis
  2. Patients with known tracheal or bronchial masses prior to endotracheal intubation
  3. Patients with known tracheal or bronchial abnormalities requiring surgical repair

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): NCT02787681


Locations
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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Riverside University Medical Center
Moreno Valley, California, United States, 92555
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: H. Bryant Nguyen, MD Loma Linda University
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Responsible Party: H. Bryant Nguyen, Professor of Medicine, Loma Linda University
ClinicalTrials.gov Identifier: NCT02787681    
Other Study ID Numbers: 5160137
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases