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

Status:	Completed
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	8/25/2017
Start Date:	August 15, 2016
End Date:	July 14, 2017

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.

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

We found this trial at

sites

VA Loma Linda Healthcare System

Loma Linda, California 92357

Principal Investigator: James D Anholm, MD

Phone: 909-558-4000

from

Loma Linda, CA