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

Loma Linda University (LLU)

Status: Completed

Conditions: Respiratory Failure

Treatments: Device: NEMO Gauge

Study type: Interventional

Funder types: Other

Identifiers

NCT02787681

5160137

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

NEMO Gauge

Experimental group

Description:

Measurement and adjustment of endotracheal tube position by stylet.

Treatment:

Device: NEMO Gauge