NCT04690517

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 2, 2021

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 21, 2020

Last Update Submit

May 30, 2021

Conditions

Cardiopulmonary Arrest

Outcome Measures

Primary Outcomes (1)

  • Accuracy

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

    during intubation procedure

Study Arms (1)

Tracheal ultrasound

OTHER

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

Procedure: tracheal ultrasound

Interventions

tracheal ultrasoundPROCEDURE

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.

Tracheal ultrasound

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23851048BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Hee Yoon, Professor

    Samsung medical center, Emergency department

    STUDY CHAIR

Central Study Contacts

Hee Yoon, Professor

CONTACT

+821099335581wildhi.yoon@samsung.com

Sooyeon Kang, fellow

CONTACT

82-10-3157-4718syrei3.kang@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 30, 2020

Study Start

January 30, 2021

Primary Completion

February 1, 2022

Study Completion

July 1, 2022

Last Updated

June 2, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)