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

Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube After Intubation of Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: NEMO Gauge

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Healthcare System
    • Moreno Valley, California, United States, 92555
      • Riverside University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Correct Endotracheal Tube Position	The number of patients with correct Endotracheal tube position	Immediate, post-intervention

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: H. Bryant Nguyen, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): July 14, 2017
• Study Completion (Actual): July 14, 2017

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 5160137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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