MedDataX Logo

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

NCT ID: NCT02787681

Last Updated: 2020-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2017-07-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NEMO Gauge

Measurement and adjustment of endotracheal tube position by stylet.

Group Type EXPERIMENTAL

NEMO Gauge

Intervention Type DEVICE

Measurement and adjustment of endotracheal tube position by stylet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NEMO Gauge

Measurement and adjustment of endotracheal tube position by stylet.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

H. Bryant Nguyen

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

H. Bryant Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

VA Loma Linda Healthcare System

Loma Linda, California, United States

Site Status

Riverside University Medical Center

Moreno Valley, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5160137

Identifier Type: -

Identifier Source: org_study_id