Learning Curve of VL for Intubation During CPR | NCT04114721

Studies
Learning Curve of VL for Intubation During CPR

NCT04114721

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Oct 31, 2019Actual

Enrollment

250Actual

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

Oct 2019

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

Oct 2, 2019

First Submission Date that Met QC Criteria

Oct 2, 2019

First Posted Date

Oct 3, 2019Actual

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

Oct 29, 2019

Last Update Posted Date

Oct 31, 2019Actual

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 endotracheal intubation (ETI) using videolaryngoscope (VL) and clinical data for cardiopulmonary resuscitation patients between 2012.03.01.-2015.02.28.

The purpose of this study is to evaluate the appropriate numbers of VL usages for successful ETI at first attempt during cardiopulmonary resuscitation.

Detailed Description

Direct layngoscope (DL) is a basic tool for endotracheal intubation(ETI) during cardiopulmonary resuscitation(CPR). ETI during CPR has higher risks of failure or delayed success with frequent attempts, misplacement of the tube, and prolonged interruptions of chest compressions. The main problems associated with ETI relate to the inherently technical difficulty in using DL. VL have various advantages of fast learning curve and overall success comparing with the DL in non-arrest patients, but there was no known data of learnig curve of successful ETI during CPR.

This study tried to estimate the the appropriate numbers of VL usage for successful ETI at first attempt during CPR. So the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of ETI using VL which in real clinical setting. In addition, this study analyze the residency training term, total number of of VL usage using VL 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

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
YES or No of successful intubation without complication	endotracheal intubation, hands-off time < 10 seconds, first trial	successful endotracheal intubation with in 60 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who suffer sudden cardiac arrest and physician tried ti intubate using viseolaryngoscope.

Exclusion Criteria:

case of requesting the do-not-attempt resuscitation befor ETI
intubated cases before arrival to emergency department
physician tried ti intubate using direct-laryngoscope

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
30025947	Background	Dagli R, Canturk M, Celik F, Erbesler ZA, Gurler M. [The role of videolaryngoscope in endotracheal intubation training programs]. Braz J Anesthesiol. 2018 Sep-Oct;68(5):447-454. doi: 10.1016/j.bjan.2018.02.008. Epub 2018 Jul 17.
25922892	Background	Bernhard M, Benger JR. Airway management during cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):183-7. doi: 10.1097/MCC.0000000000000201.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases