Cardiopulmonary ArrestNCT04451733
Effect of ETI Performance on CPR Outcomes
An observational study of Cardiopulmonary Arrest, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
This is a clinical observation study based on analysis of video-clip data of cardiopulmonary resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the outcome of OHCA patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in an urban emergency department at a tertiary hospital in Seoul, Korea
Who may be able to join
- patients who suffered sudden cardiac arrest and intubated during CPR
Who cannot join
- case of requesting the do-not-atempt resuscitation
- patients who were diagnosed as adavanced cancer
- cardiac arrest by multiple trauma
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Emergency Medicine, Konkuk University Medical center
Seoul, 143-729
About this study
Official title: Effect of Endotracheal Intubation Performance on the Outcomes in out-of Hospital Cardiac Arrest Patients
This is a clinical observation study based on analysis of video-clip data of cardiopulmonary resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the outcome of OHCA patients.
Read the detailed description
ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known detailed data of explaining this issues.
This study tried to evaluate effect of factors of ETI including numbers of trial, time for ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA patients.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- Endotracheal intubation
- Keywords
- intubation, Cardiopulmonary Arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationProcedure or surgery
Perform the endotracheal intubation during CPR
What is being measured
The primary outcome is the main question the study is designed to answer.
Good Neurologic outcome
survival with good neurologic status (CPC 1-2) after suffering cardiac arrest
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang O, Park, Konkuk University Medical Center
- Investigators
- Sang O Park, MD, PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451733
- Sponsor's protocol ID
- INTU_CPRoutcome
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osman AD, Rahman MA, Lam L, Lin CC, Yeoh M, Judkins S, Pratten N, Moran J, Jones D. Cardiopulmonary resuscitation and endotracheal intubation decisions for adults with advance care directive and resuscitation plans in the emergency department. Australas Emerg Care. 2020 Dec;23(4):247-251. doi: 10.1016/j.auec.2020.05.003. Epub 2020 Jun 11.
PubMed 32534981Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.
PubMed 31722552Newell C, Grier S, Soar J. Airway and ventilation management during cardiopulmonary resuscitation and after successful resuscitation. Crit Care. 2018 Aug 15;22(1):190. doi: 10.1186/s13054-018-2121-y.
PubMed 30111343Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.
PubMed 26472995
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endotracheal Intubation Performance on the Outcomes in out-of Hospital Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT04451733
- Acronym / sponsor ID
- INTU_CPRoutcome
- Conditions
- Cardiopulmonary Arrest
- Keywords
- intubation, Cardiopulmonary Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical observation study based on analysis of video-clip data of cardiopulmonary resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the outcome of OHCA patients.
Detailed description
ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known detailed data of explaining this issues.
This study tried to evaluate effect of factors of ETI including numbers of trial, time for ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in an urban emergency department at a tertiary hospital in Seoul, Korea
Key inclusion criteria (1 listed)
- patients who suffered sudden cardiac arrest and intubated during CPR
Key exclusion criteria (3 listed)
- case of requesting the do-not-atempt resuscitation
- patients who were diagnosed as adavanced cancer
- cardiac arrest by multiple trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal intubationPerform the endotracheal intubation during CPR | Procedure or surgery | – |
Primary outcome
Good Neurologic outcome
Time frame: 1 year
survival with good neurologic status (CPC 1-2) after suffering cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 32534981Osman AD, Rahman MA, Lam L, Lin CC, Yeoh M, Judkins S, Pratten N, Moran J, Jones D. Cardiopulmonary resuscitation and endotracheal intubation decisions for adults with advance care directive and resuscitation plans in the emergency department. Australas Emerg Care. 2020 Dec;23(4):247-251. doi: 10.1016/j.auec.2020.05.003. Epub 2020 Jun 11.
- Background: PubMed 31722552Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.
- Background: PubMed 30111343Newell C, Grier S, Soar J. Airway and ventilation management during cardiopulmonary resuscitation and after successful resuscitation. Crit Care. 2018 Aug 15;22(1):190. doi: 10.1186/s13054-018-2121-y.
- Background: PubMed 26472995Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang O Park, MD, PhD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Arrest, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good Neurologic outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451733, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.