Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR Wearing PPE

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04690517
Collaborator
(none)
34
1
1
17
2

Study Details

Study Description

Brief Summary

It is very important to ensure the tube placement in patients with cardiac arrest and unrecognized misplacement of endo-tracheal tube can lead to morbidity and mortality. In recent pandemic situations such as COVID-19 (Coronavirus disease-19), the number of cases of cardiopulmonary resuscitation with personal protective equipment (PPE) have increased. In those cases, existing methods such as auscultation and chest uprising have to be limited. Quantitative waveform capnography is recommended as the gold standard for confirming correct endotracheal tube placement in the 2010 American HeartAssociation (AHA) Guidelines for Cardiopulmonary resuscitation (CPR) and Emergency Cardiovascular Care (ECC), but it has some well-known limitations in cardiac arrest patients.

Ultrasonography is a non-invasive, real-time diagnostic tool commonly used during resuscitation. Especially, tracheal ultrasonography can be performed in real-time when the tube is passed through the trachea or esophagus. Previous prospective studies revealed that tracheal ultrasonography could feasibly and rapidly confirm tracheal intubation during emergency intubation.

There have already been several studies comparing the accuracy of tracheal ultrasound and capnography, but there was no study comparing the two tools under the constraints of PPE that is essential in pandemic situations as in this study. This study aimed to determine the accuracy of tracheal ultrasonography in assessing endotracheal tube position during CPR with PPE.

Condition or Disease Intervention/Treatment Phase
  • Procedure: tracheal ultrasound
N/A

Detailed Description

When patients in cardiopulmonary arrest enter a emergency room (ER) or patients staying in a ER have a cardiopulmonary arrest, participants perform intubation and CPR. When it is judged as a high-risk group with a high probability of droplet infection, all participants in resuscitation team should wear personal protective equipment. Tracheal ultrasound and end-tidal carbon dioxide are used to confirm the placement of tube. The gold standard is the direct visualization using laryngoscope. The time it takes to confirm the placement of tube is also measured.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR (Cardiopulmonary Resuscitation) Wearing PPE (Personnel Protective Equipment): A Prospective Comparative Study
Actual Study Start Date :
Jan 30, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Tracheal ultrasound

The patients in cardiopulmonary arrest should be performed tracheal ultrasound when tube is passed through the trachea or esophagus.

Procedure: tracheal ultrasound
When checking tracheal ultrasound, several signs are used in judgements. Direct signs include reverberation artifact and double ring sign. Indirect sign means checking the bilateral lung sliding.

Outcome Measures

Primary Outcome Measures

  1. Accuracy [during intubation procedure]

    The gold standard is direct visualization using laryngoscopy. Tracheal ultrasound is performed regardless of whether it is in real-time or not.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. cardiopulmonary arrest patients receiving emergency intubation and CPR
    1. patients judged to need to wear PPE according to the judgement of the clinician
Exclusion Criteria:
    1. sign for "do not resuscitate (DNR)"
    1. patients unable to perform tracheal ultrasound due to trauma of the site
    1. patients unable to perform tracheal ultrasound due to oropharynx cancer
    1. patients unable to perform tracheal ultrasound due to placement of tracheal cannula
    1. patients not used tracheal ultrasound for checking tube placement

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Study Chair: Hee Yoon, Professor, Samsung medical center, Emergency department

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT04690517
Other Study ID Numbers:
  • 2020-11-115
First Posted:
Dec 30, 2020
Last Update Posted:
Jun 2, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2021