- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391857
Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS) (EGD_ACLS)
March 5, 2018 updated by: Sang O, Park, Konkuk University Medical Center
The Clinical Study for the Identifying the Effect of Early Gastric Decompression on Improvement of Circulation During Advanced Cardiopulmonary Resuscitation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 143-729
- Department of Emergency Medicine, Konkuk University Medical center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EGDgroup
Intervention (gastric decompression by naso(oro)-gastric tube insertion) was performed
|
Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Within 10-20 min of CPR
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean compression depth of Chest compression
Time Frame: Within 10-20 min of CPR
|
Within 10-20 min of CPR
|
|
Mean compression rate of Chest compression
Time Frame: Within 10-20 min of CPR
|
Within 10-20 min of CPR
|
|
proportions of corrected release of Chest compression
Time Frame: Within 10-20 min of CPR
|
Within 10-20 min of CPR
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sang O Park, MD, Department of Emergency Medicine, School of medicine, Konkuk University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 12, 2015
First Posted (Estimate)
March 18, 2015
Study Record Updates
Last Update Posted (Actual)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 5, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGD2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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