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Completed

NCT Number: NCT04419064

Confirmation of Ventilation and Intubation by Determination With Ultrasonography

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.

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Key information

Conditions

Critical Illness Disease Attributes Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of Care Ultrasound

Diagnostic Test

Tracheal and lung ultrasonography

Primary outcomes

  1. Concordance with next occurring chest radiograph

    Time frame: within 24 hours

    Adequate endotracheal tube position in agreement with chest radiograph

Secondary outcomes

  1. Esophageal Intubation detection

    Time frame: within intubation attempt

    Number of esophageal intubations detected during intubation attempt

  2. Right main or endobronchial intubation

    Time frame: within intubation attempt

    Number of right main stem intubations detected with ultrasonography

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COVID-US

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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