Early Gastric Decompression During Advanced Cardiopulmona... | NCT02391857

Studies
Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)

NCT02391857

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Mar 7, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Gastric decompression

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

Mar 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, 2015Actual

Primary Completion Date

Dec 1, 2016Actual

Completion Date

Jan 1, 2018Actual

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 18, 2015Estimated

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

Mar 5, 2018

Last Update Posted Date

Mar 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sang O, Park, Assistant 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

Not provided

Is FDA Regulated Device

Not provided

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 study aimed to identify the effect of early gastric decompression on the improvement of circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting of emergency department.

Detailed Description

Subjects and setting : adult sudden cardiac arrest patients in out of hospital, and transported to emergency department for advanced resuscitation treatment Interventions: first step, establish the advanced airway, after then insertion the naso (or oro)-gastric tube during CPR Data collection: live observation and review the automatically recoding data Missing or failed data should be collected and descriped Study period and sample size: numbers of participants necessary to identify the effect of interventions; 12 months or lesser were anticipated Analysis: All collected data can be analysed by Statistical programs

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EGDgroup	Experimental	Intervention (gastric decompression by naso(oro)-gastric tube insertion) was performed	Procedure: Gastric decompression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric decompression	Procedure	Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR	EGDgroup

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of improvement of circulatuion during CPR by evalution of increased end tidal CO2 (ETCO2) durig CPR		Within 10-20 min of CPR

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Mean compression depth of Chest compression		Within 10-20 min of CPR
Mean compression rate of Chest compression		Within 10-20 min of CPR
proportions of corrected release of Chest compression

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Out of cardiac arrest patients who was transported to the emergency department for advanced resuscitation care

Exclusion Criteria:

Do not attempted
Inevitable death cofirmed at Emergency department
Early recovery of spontaneous circulation before the intervention or sufficient collections of outcome data
data loss
others

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang O Park, MD	Department of Emergency Medicine, School of medicine, Konkuk University	Study Director

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
9863573	Background	Wenzel V, Idris AH, Banner MJ, Kubilis PS, Band R, Williams JL Jr, Lindner KH. Respiratory system compliance decreases after cardiopulmonary resuscitation and stomach inflation: impact of large and small tidal volumes on calculated peak airway pressure. Resuscitation. 1998 Aug;38(2):113-8. doi: 10.1016/s0300-9572(98)00095-1.
16192785

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases