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Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS) (EGD_ACLS)

Primary Purpose

Out-of-Hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gastric decompression
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest focused on measuring cardiopulmonary resuscitation, Gastric emptying

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Emergency Medicine, Konkuk University Medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EGDgroup

Arm Description

Intervention (gastric decompression by naso(oro)-gastric tube insertion) was performed

Outcomes

Primary Outcome Measures

Evidence of improvement of circulatuion during CPR by evalution of increased end tidal CO2 (ETCO2) durig CPR

Secondary Outcome Measures

Full Information

First Posted
March 9, 2015
Last Updated
March 5, 2018
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02391857
Brief Title
Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)
Acronym
EGD_ACLS
Official Title
The Clinical Study for the Identifying the Effect of Early Gastric Decompression on Improvement of Circulation During Advanced Cardiopulmonary Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
cardiopulmonary resuscitation, Gastric emptying

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGDgroup
Arm Type
Experimental
Arm Description
Intervention (gastric decompression by naso(oro)-gastric tube insertion) was performed
Intervention Type
Procedure
Intervention Name(s)
Gastric decompression
Intervention Description
Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR
Primary Outcome Measure Information:
Title
Evidence of improvement of circulatuion during CPR by evalution of increased end tidal CO2 (ETCO2) durig CPR
Time Frame
Within 10-20 min of CPR
Other Pre-specified Outcome Measures:
Title
Mean compression depth of Chest compression
Time Frame
Within 10-20 min of CPR
Title
Mean compression rate of Chest compression
Time Frame
Within 10-20 min of CPR
Title
proportions of corrected release of Chest compression
Time Frame
Within 10-20 min of CPR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang O Park, MD
Organizational Affiliation
Department of Emergency Medicine, School of medicine, Konkuk University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Emergency Medicine, Konkuk University Medical center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
9863573
Citation
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.
Results Reference
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PubMed Identifier
16192785
Citation
Gabrielli A, Wenzel V, Layon AJ, von Goedecke A, Verne NG, Idris AH. Lower esophageal sphincter pressure measurement during cardiac arrest in humans: potential implications for ventilation of the unprotected airway. Anesthesiology. 2005 Oct;103(4):897-9. doi: 10.1097/00000542-200510000-00031. No abstract available.
Results Reference
background
PubMed Identifier
20956221
Citation
Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939. Erratum In: Circulation. 2011 Oct 11;124(15):e402.
Results Reference
background
PubMed Identifier
9468177
Citation
Wenzel V, Idris AH, Banner MJ, Kubilis PS, Williams JL Jr. Influence of tidal volume on the distribution of gas between the lungs and stomach in the nonintubated patient receiving positive-pressure ventilation. Crit Care Med. 1998 Feb;26(2):364-8. doi: 10.1097/00003246-199802000-00042.
Results Reference
background
PubMed Identifier
15531063
Citation
von Goedecke A, Wagner-Berger HG, Stadlbauer KH, Krismer AC, Jakubaszko J, Bratschke C, Wenzel V, Keller C. Effects of decreasing peak flow rate on stomach inflation during bag-valve-mask ventilation. Resuscitation. 2004 Nov;63(2):131-6. doi: 10.1016/j.resuscitation.2004.04.012.
Results Reference
background
PubMed Identifier
15066941
Citation
Aufderheide TP, Sigurdsson G, Pirrallo RG, Yannopoulos D, McKnite S, von Briesen C, Sparks CW, Conrad CJ, Provo TA, Lurie KG. Hyperventilation-induced hypotension during cardiopulmonary resuscitation. Circulation. 2004 Apr 27;109(16):1960-5. doi: 10.1161/01.CIR.0000126594.79136.61. Epub 2004 Apr 5.
Results Reference
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Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)

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