NCT04419064

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

June 2, 2020

Last Update Submit

October 7, 2020

Conditions

Critical IllnessMechanical Ventilation

Keywords

intubationbedside ultrasoundpoint-of-care ultrasound

Outcome Measures

Primary Outcomes (1)

  • Concordance with next occurring chest radiograph

    Adequate endotracheal tube position in agreement with chest radiograph

    within 24 hours

Secondary Outcomes (2)

  • Esophageal Intubation detection

    within intubation attempt

  • Right main or endobronchial intubation

    within intubation attempt

Interventions

Point of care ultrasoundDIAGNOSTIC_TEST

Tracheal and lung ultrasonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15217, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Kadlec Regional Medical Center

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mourad H Senussi, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor of Medicine

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 5, 2020

Study Start

January 1, 2019

Primary Completion

May 20, 2020

Study Completion

May 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)