Cardiopulmonary ArrestNCT03423745

Appropriate Number of Endotracheal Intubation Experience for CPR

An observational study of Cardiopulmonary Arrest, run by Konkuk University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a clinical study based on analysis of video-clip data of intubation and clinical data for cardiopulmonary resuscitation patients between 2011.03.01.-2012.02.28.. Aim of this study is to estimate the appropriate number of endotracheal intubation(ETI) experience for successful ETI at first attempt during… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiopulmonary Arrest
How many people: 140 participants
Where: 1 siteSouth Korea
Study dates: 1 Mar 2007to 29 Feb 2012
How long will I take part?: 1 Month
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: emergency physicians in an urban ED at a tertiary training hospital in Seoul, Republic of Korea

Who may be able to join

patients who suffer sudden cardiac arrest

Who cannot join

case of requesting the do-not-attempt resuscitation befor ETI
intubated cases before arrival to emergency department

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Emergency Medicine, Konkuk University Medical center
Seoul, 143-729

Other trials in South Korea

About this study

Official title: Appropriate Number of Endotracheal Intubation Experience for First Attempt Successful Endotracheal Intubation During Cardiopulmonary Resuscitation

Read the detailed description

Endotracheal intubation(ETI) has been considered to be the best method of airway management during cardiopulmonary resuscitation(CPR). However, ETI during CPR requires high skill and experience. Therefore ETI during CPR should be performed by expert in ETI. But the definition of experts in ETI during CPR has not been done yet.

This study tried to estimate the appropriate number of ETI experience for successful ETI at first attempt during cardiopulmonary resuscitation. So the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of ETI using direct laryngoscopy (DL) which is standard device, in real clinical setting. In addition, this study analyze the residency training term, total number of ETI experience using DL at that time.

Conditions: Cardiopulmonary Arrest
Keywords: intubation, cardiopulmonary resuscitation, number of endotracheal intubation experience
Medical subject headings: Heart Arrest

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful intubation during CPR
endotracheal intubation, hands-off time < 10 seconds, first trial
Measured: successful endotracheal intubation with in 120 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 200729 Feb 2012

First posted6 Feb 2018
Study start1 Mar 2007
Primary completion29 Feb 2012
Study completion29 Feb 2012

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: 140 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT03423745
Sponsor's protocol ID: CPRintuexperience
Status last verified: Feb 2018
First submitted: 25 Dec 2017
Last updated: 19 Feb 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.
PubMed 26477701
Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.
PubMed 19573949
Je S, Cho Y, Choi HJ, Kang B, Lim T, Kang H. An application of the learning curve-cumulative summation test to evaluate training for endotracheal intubation in emergency medicine. Emerg Med J. 2015 Apr;32(4):291-4. doi: 10.1136/emermed-2013-202470. Epub 2013 Oct 23.
PubMed 24154942
Mulcaster JT, Mills J, Hung OR, MacQuarrie K, Law JA, Pytka S, Imrie D, Field C. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003 Jan;98(1):23-7. doi: 10.1097/00000542-200301000-00007.
PubMed 12502974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Compression-Only Versus Standard Basic Life Support Training in Nursing Students
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
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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
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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All Cardiopulmonary Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Appropriate Number of Endotracheal Intubation Experience for First Attempt Successful Endotracheal Intubation During Cardiopulmonary Resuscitation
ClinicalTrials.gov ID: NCT03423745
Acronym / sponsor ID: CPRintuexperience
Conditions: Cardiopulmonary Arrest
Keywords: intubation, cardiopulmonary resuscitation, number of endotracheal intubation experience
Study type: Observational
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Konkuk University Medical CenterUniversity, hospital or other
Study start: 1 Mar 2007 (actual)
Primary completion: 29 Feb 2012 (actual)
Study completion: 29 Feb 2012 (actual)
First posted: 6 Feb 2018 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: emergency physicians in an urban ED at a tertiary training hospital in Seoul, Republic of Korea

Key inclusion criteria (1 listed)

patients who suffer sudden cardiac arrest

Key exclusion criteria (2 listed)

case of requesting the do-not-attempt resuscitation befor ETI
intubated cases before arrival to emergency department

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Successful intubation during CPR
Time frame: successful endotracheal intubation with in 120 seconds
endotracheal intubation, hands-off time < 10 seconds, first trial

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 19 Feb 2018.
Background: PubMed 26477701Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.
Background: PubMed 19573949Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.
Background: PubMed 24154942Je S, Cho Y, Choi HJ, Kang B, Lim T, Kang H. An application of the learning curve-cumulative summation test to evaluate training for endotracheal intubation in emergency medicine. Emerg Med J. 2015 Apr;32(4):291-4. doi: 10.1136/emermed-2013-202470. Epub 2013 Oct 23.
Background: PubMed 12502974Mulcaster JT, Mills J, Hung OR, MacQuarrie K, Law JA, Pytka S, Imrie D, Field C. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003 Jan;98(1):23-7. doi: 10.1097/00000542-200301000-00007.

Related trials for Cardiopulmonary Arrest

Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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
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, M.D., PhD principal investigator

Department of Emergency Medicine, 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 2 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 19 Feb 2018. 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?

Successful intubation during CPR (time frame: successful endotracheal intubation with in 120 seconds). 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 NCT03423745, 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 19 Feb 2018.