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Clinical Trials/NCT02787681
NCT02787681CompletedNot Applicable

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

Loma Linda University3 sites in 1 country71 target enrollmentStarted: August 15, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
71
Locations
3
Primary Endpoint
Number of Correct Endotracheal Tube Position
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
  • •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
  • •Endotracheal tube size 7.0 mm to 8.5 mm in diameter

Exclusion Criteria

  • •Patients with active hemoptysis
  • •Patients with known tracheal or bronchial masses prior to endotracheal intubation
  • •Patients with known tracheal or bronchial abnormalities requiring surgical repair

Arms & Interventions

NEMO Gauge

Experimental

Measurement and adjustment of endotracheal tube position by stylet.

Intervention: NEMO Gauge (Device)

Outcomes

Primary Outcomes

Number of Correct Endotracheal Tube Position

Time Frame: Immediate, post-intervention

The number of patients with correct Endotracheal tube position

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

H. Bryant Nguyen

Professor of Medicine

Loma Linda University

Study Sites (3)

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