Confirmation of Ventilation and Intubation by Determination With Ultrasonography

Critical Illness Clinical Trial

— COVID-US  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419064
• Other study ID #: STUDY20050011
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: October 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 30, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation

Intervention

Diagnostic Test:
• Point of care ultrasound
Tracheal and lung ultrasonography

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Kadlec Regional Medical Center	Richland	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of Pittsburgh	Baylor College of Medicine, Kadlec Regional Medical Center, Oregon Health and Science University, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance with next occurring chest radiograph	Adequate endotracheal tube position in agreement with chest radiograph	within 24 hours
Secondary	Esophageal Intubation detection	Number of esophageal intubations detected during intubation attempt	within intubation attempt
Secondary	Right main or endobronchial intubation	Number of right main stem intubations detected with ultrasonography	within intubation attempt