Confirmation of Ventilation and Intubation by Determination With Ultrasonography (COVID-US)

October 7, 2020 updated by: Mourad Senussi, University of Pittsburgh

Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study

Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endotracheal intubation is an important aspect of managing critically ill patients. Chest radiography remains the gold standard for confirming endotracheal tube positioning, however, ultrasonography can be a useful alternative. The objective of this study is to determine the feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate positioning of endotracheal tube placement in a cohort of critically ill participants including those with novel coronavirus-2019.

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15217
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center
    • Washington
      • Richland, Washington, United States, 99352
        • Kadlec Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients, > 18 years of age, undergoing intubation and mechanical ventilation from 4 multiple intensive care units from 4 different academic and community hospitals.

Description

Inclusion Criteria:

  • Adult patients (> or equal to 18 years of age) requiring intubation and mechanical ventilation as a part of their routine care

Exclusion Criteria:

  • Recent neck or chest surgery
  • Cervical spine immobilization
  • Lack of availability of operators or equipment for performing the ultrasound protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance with next occurring chest radiograph
Time Frame: within 24 hours
Adequate endotracheal tube position in agreement with chest radiograph
within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal Intubation detection
Time Frame: within intubation attempt
Number of esophageal intubations detected during intubation attempt
within intubation attempt
Right main or endobronchial intubation
Time Frame: within intubation attempt
Number of right main stem intubations detected with ultrasonography
within intubation attempt

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Baylor College of Medicine
The Cleveland Clinic
Oregon Health and Science University
Kadlec Regional Medical Center

Investigators

  • Principal Investigator: Mourad H Senussi, MD, MS, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

May 20, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20050011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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