Confirmation of Ventilation and Intubation by Determination With Ultrasonography

Completed

• Conditions: Mechanical Ventilation; Critical Illness

• Registration Number: NCT04419064
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-30
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance with next occurring chest radiograph	within 24 hours	Adequate endotracheal tube position in agreement with chest radiograph

Secondary Outcome Measures

Name	Time	Method
Right main or endobronchial intubation	within intubation attempt	Number of right main stem intubations detected with ultrasonography
Esophageal Intubation detection	within intubation attempt	Number of esophageal intubations detected during intubation attempt

Trial Locations

Locations (4)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

Kadlec Regional Medical Center; 🇺🇸 Richland, Washington, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States