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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787681
• Other study ID #: 5160137
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: July 14, 2017

Study information

• Verified date: October 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• NEMO Gauge
Measurement and adjustment of endotracheal tube position by stylet.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Riverside University Medical Center	Moreno Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Correct Endotracheal Tube Position	The number of patients with correct Endotracheal tube position	Immediate, post-intervention