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

Primary Purpose

Cardiopulmonary Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tracheal ultrasound
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiopulmonary Arrest

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. cardiopulmonary arrest patients receiving emergency intubation and CPR
  • 2. patients judged to need to wear PPE according to the judgement of the clinician

Exclusion Criteria:

  • 1. sign for "do not resuscitate (DNR)"
  • 2. patients unable to perform tracheal ultrasound due to trauma of the site
  • 3. patients unable to perform tracheal ultrasound due to oropharynx cancer
  • 4. patients unable to perform tracheal ultrasound due to placement of tracheal cannula
  • 5. patients not used tracheal ultrasound for checking tube placement

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tracheal ultrasound

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 21, 2020
Last Updated
May 30, 2021
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04690517
Brief Title
Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR Wearing PPE
Official Title
Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR (Cardiopulmonary Resuscitation) Wearing PPE (Personnel Protective Equipment): A Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tracheal ultrasound
Arm Type
Other
Arm Description
The patients in cardiopulmonary arrest should be performed tracheal ultrasound when tube is passed through the trachea or esophagus.
Intervention Type
Procedure
Intervention Name(s)
tracheal ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy
Description
The gold standard is direct visualization using laryngoscopy. Tracheal ultrasound is performed regardless of whether it is in real-time or not.
Time Frame
during intubation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. cardiopulmonary arrest patients receiving emergency intubation and CPR 2. patients judged to need to wear PPE according to the judgement of the clinician Exclusion Criteria: 1. sign for "do not resuscitate (DNR)" 2. patients unable to perform tracheal ultrasound due to trauma of the site 3. patients unable to perform tracheal ultrasound due to oropharynx cancer 4. patients unable to perform tracheal ultrasound due to placement of tracheal cannula 5. patients not used tracheal ultrasound for checking tube placement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Yoon, Professor
Phone
+821099335581
Email
wildhi.yoon@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sooyeon Kang, fellow
Phone
82-10-3157-4718
Email
syrei3.kang@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Yoon, Professor
Organizational Affiliation
Samsung medical center, Emergency department
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Yoon, Professor
Phone
82-10-9933-5581
Email
wildhi.yoon@samsung.com
First Name & Middle Initial & Last Name & Degree
Sooyeon Kang, fellow
Phone
82-10-3157-4718
Email
syrei3.kang@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23851048
Citation
Chou HC, Chong KM, Sim SS, Ma MH, Liu SH, Chen NC, Wu MC, Fu CM, Wang CH, Lee CC, Lien WC, Chen SC. Real-time tracheal ultrasonography for confirmation of endotracheal tube placement during cardiopulmonary resuscitation. Resuscitation. 2013 Dec;84(12):1708-12. doi: 10.1016/j.resuscitation.2013.06.018. Epub 2013 Jul 9.
Results Reference
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Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR Wearing PPE

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