Effect of ETI Performance on CPR Outcomes | NCT04451733

Studies
Effect of ETI Performance on CPR Outcomes

NCT04451733

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Jun 30, 2020Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Cardiopulmonary Arrest

Interventions

Endotracheal intubation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012Actual

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jun 25, 2020

First Submission Date that Met QC Criteria

Jun 25, 2020

First Posted Date

Jun 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2020

Last Update Posted Date

Jun 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sang O, Park, Associate Professor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a clinical observation study based on analysis of video-clip data of cardiopulmonary resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the outcome of OHCA patients.

Detailed Description

ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known detailed data of explaining this issues.

This study tried to evaluate effect of factors of ETI including numbers of trial, time for ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endotracheal intubation	Procedure	Perform the endotracheal intubation during CPR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Good Neurologic outcome	survival with good neurologic status (CPC 1-2) after suffering cardiac arrest	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who suffered sudden cardiac arrest and intubated during CPR

Exclusion Criteria:

case of requesting the do-not-atempt resuscitation
patients who were diagnosed as adavanced cancer
cardiac arrest by multiple trauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients in an urban emergency department at a tertiary hospital in Seoul, Korea

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang O Park, MD, PhD	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Emergency Medicine, Konkuk University Medical center		Seoul		143-729	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32534981	Background	Osman AD, Rahman MA, Lam L, Lin CC, Yeoh M, Judkins S, Pratten N, Moran J, Jones D. Cardiopulmonary resuscitation and endotracheal intubation decisions for adults with advance care directive and resuscitation plans in the emergency department. Australas Emerg Care. 2020 Dec;23(4):247-251. doi: 10.1016/j.auec.2020.05.003. Epub 2020 Jun 11.
31722552

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques