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

Loma Linda University (LLU) logo

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)

71 participants in 1 patient group

NEMO Gauge
Experimental group
Description:
Measurement and adjustment of endotracheal tube position by stylet.
Treatment:
Device: NEMO Gauge

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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