NCT02391857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

March 9, 2015

Last Update Submit

March 5, 2018

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

cardiopulmonary resuscitationGastric emptying

Outcome Measures

Primary Outcomes (1)

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

    Within 10-20 min of CPR

Other Outcomes (3)

  • 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

    Within 10-20 min of CPR

Study Arms (1)

EGDgroup

EXPERIMENTAL

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

Procedure: Gastric decompression

Interventions

Gastric decompressionPROCEDURE

Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR

EGDgroup

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, Konkuk University Medical center

Seoul, 143-729, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 9863573BACKGROUND

  • 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.

    PMID: 16192785BACKGROUND

  • 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.

    PMID: 20956221BACKGROUND

  • 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.

    PMID: 9468177BACKGROUND

  • 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.

    PMID: 15531063BACKGROUND

  • 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.

    PMID: 15066941BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Sang O Park, MD

    Department of Emergency Medicine, School of medicine, Konkuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

KR(1)