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

NCT02787681 | Completed Results FDA Device

• 1 other identifier: 5160137
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Number of Correct Endotracheal Tube Position

  The number of patients with correct Endotracheal tube position

  Immediate, post-intervention

Study Arms (1)

NEMO Gauge

EXPERIMENTAL

Measurement and adjustment of endotracheal tube position by stylet.

Device: NEMO Gauge

Interventions

NEMO Gauge DEVICE

Measurement and adjustment of endotracheal tube position by stylet.

NEMO Gauge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (3)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

Riverside University Medical Center

Moreno Valley, California, 92555, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: H. Bryant Nguyen, MD
• Organization: Loma Linda University

hbnguyen@llu.edu

909-558-4000

Study Officials

• H. Bryant Nguyen, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: August 15, 2016
• Primary Completion: July 14, 2017
• Study Completion: July 14, 2017
• Last Updated: November 9, 2020
• Results First Posted: November 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)