N/A
N=71
Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube
Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02787681 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Correct Endotracheal Tube Position — 64 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NEMO Gauge (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Correct Endotracheal Tube Position |
64 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02787681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.