Back to resultsMulti-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEMO Gauge
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
- 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
- Endotracheal tube size 7.0 mm to 8.5 mm in diameter
Exclusion Criteria:
- Patients with active hemoptysis
- Patients with known tracheal or bronchial masses prior to endotracheal intubation
- Patients with known tracheal or bronchial abnormalities requiring surgical repair
Sites / Locations
- Loma Linda University Medical Center
- VA Loma Linda Healthcare System
- Riverside University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NEMO Gauge
Arm Description
Measurement and adjustment of endotracheal tube position by stylet.
Outcomes
Primary Outcome Measures
Number of Correct Endotracheal Tube Position
The number of patients with correct Endotracheal tube position
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02787681
Brief Title
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube
Official Title
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube After Intubation of Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NEMO Gauge
Arm Type
Experimental
Arm Description
Measurement and adjustment of endotracheal tube position by stylet.
Intervention Type
Device
Intervention Name(s)
NEMO Gauge
Intervention Description
Measurement and adjustment of endotracheal tube position by stylet.
Primary Outcome Measure Information:
Title
Number of Correct Endotracheal Tube Position
Description
The number of patients with correct Endotracheal tube position
Time Frame
Immediate, post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
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
Endotracheal tube size 7.0 mm to 8.5 mm in diameter
Exclusion Criteria:
Patients with active hemoptysis
Patients with known tracheal or bronchial masses prior to endotracheal intubation
Patients with known tracheal or bronchial abnormalities requiring surgical repair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Bryant Nguyen, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
VA Loma Linda Healthcare System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Riverside University Medical Center
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube
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