Appropriate Number of Endotracheal Intubation Experience... | NCT03423745

Studies
Appropriate Number of Endotracheal Intubation Experience for CPR

NCT03423745

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Feb 19, 2018Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Cardiopulmonary Arrest

Interventions

Not provided

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

Feb 2018

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 1, 2007Actual

Primary Completion Date

Feb 29, 2012Actual

Completion Date

Feb 29, 2012Actual

First Submitted Date

Dec 25, 2017

First Submission Date that Met QC Criteria

Feb 5, 2018

First Posted Date

Feb 6, 2018Actual

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

Feb 15, 2018

Last Update Posted Date

Feb 19, 2018Actual

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 study based on analysis of video-clip data of intubation and clinical data for cardiopulmonary resuscitation patients between 2011.03.01.-2012.02.28.. Aim of this study is to estimate the appropriate number of endotracheal intubation(ETI) experience for successful ETI at first attempt during cardiopulmonary resuscitation.

Detailed Description

Endotracheal intubation(ETI) has been considered to be the best method of airway management during cardiopulmonary resuscitation(CPR). However, ETI during CPR requires high skill and experience. Therefore ETI during CPR should be performed by expert in ETI. But the definition of experts in ETI during CPR has not been done yet.

This study tried to estimate the appropriate number of ETI experience for successful ETI at first attempt during cardiopulmonary resuscitation. So the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of ETI using direct laryngoscopy (DL) which is standard device, in real clinical setting. In addition, this study analyze the residency training term, total number of ETI experience using DL at that time.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful intubation during CPR	endotracheal intubation, hands-off time < 10 seconds, first trial	successful endotracheal intubation with in 120 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who suffer sudden cardiac arrest

Exclusion Criteria:

case of requesting the do-not-attempt resuscitation befor ETI
intubated cases before arrival to emergency department

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

emergency physicians in an urban ED at a tertiary training hospital in Seoul, Republic of Korea

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang O Park, M.D., PhD	Department of Emergency Medicine, 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
26477701	Background	Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.
19573949

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases