Cardiopulmonary ArrestNCT04114721
Learning Curve of VL for Intubation During CPR
An observational study of Cardiopulmonary Arrest, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
This is a clinical study based on analysis of video-clip data of endotracheal intubation (ETI) using videolaryngoscope (VL) and clinical data for cardiopulmonary resuscitation patients between 2012.03.01.-2015.02.28. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Feb 2015
- 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 and physician tried ti intubate using viseolaryngoscope.
Who cannot join
- case of requesting the do-not-attempt resuscitation befor ETI
- intubated cases before arrival to emergency department
- physician tried ti intubate using direct-laryngoscope
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: Learning Curve of Video-laryngoscope (VL) for First Attempt Successful Endotracheal Intubation During Cardiopulmonary Resuscitation (CPR)
This is a clinical study based on analysis of video-clip data of endotracheal intubation (ETI) using videolaryngoscope (VL) and clinical data for cardiopulmonary resuscitation patients between 2012.03.01.-2015.02.28.
The purpose of this study is to evaluate the appropriate numbers of VL usages for successful ETI at first attempt during cardiopulmonary resuscitation.
Read the detailed description
Direct layngoscope (DL) is a basic tool for endotracheal intubation(ETI) during cardiopulmonary resuscitation(CPR). ETI during CPR has higher risks of failure or delayed success with frequent attempts, misplacement of the tube, and prolonged interruptions of chest compressions. The main problems associated with ETI relate to the inherently technical difficulty in using DL. VL have various advantages of fast learning curve and overall success comparing with the DL in non-arrest patients, but there was no known data of learnig curve of successful ETI during CPR.
This study tried to estimate the the appropriate numbers of VL usage for successful ETI at first attempt during CPR. So the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of ETI using VL which in real clinical setting. In addition, this study analyze the residency training term, total number of of VL usage using VL at that time.
- Conditions
- Cardiopulmonary Arrest
- Keywords
- intubation, cardiopulmonary resuscitation, Learning curve, videolaryngoscope
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
YES or No of successful intubation without complication
endotracheal intubation, hands-off time < 10 seconds, first trial
Measured: successful endotracheal intubation with in 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- 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)
- Target duration
- 1 Month
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, M.D., PhD, Principal investigator, Department of Emergency Medicine, Konkuk University Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114721
- Sponsor's protocol ID
- CPRintuexperience_VL
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dagli R, Canturk M, Celik F, Erbesler ZA, Gurler M. [The role of videolaryngoscope in endotracheal intubation training programs]. Braz J Anesthesiol. 2018 Sep-Oct;68(5):447-454. doi: 10.1016/j.bjan.2018.02.008. Epub 2018 Jul 17.
PubMed 30025947Bernhard M, Benger JR. Airway management during cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):183-7. doi: 10.1097/MCC.0000000000000201.
PubMed 25922892Buis ML, Maissan IM, Hoeks SE, Klimek M, Stolker RJ. Defining the learning curve for endotracheal intubation using direct laryngoscopy: A systematic review. Resuscitation. 2016 Feb;99:63-71. doi: 10.1016/j.resuscitation.2015.11.005. Epub 2015 Dec 19.
PubMed 26711127Park SO, Baek KJ, Hong DY, Kim SC, Lee KR. Feasibility of the video-laryngoscope (GlideScope(R)) for endotracheal intubation during uninterrupted chest compressions in actual advanced life support: a clinical observational study in an urban emergency department. Resuscitation. 2013 Sep;84(9):1233-7. doi: 10.1016/j.resuscitation.2013.03.026. Epub 2013 Mar 26.
PubMed 23541527
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Video-laryngoscope (VL) for First Attempt Successful Endotracheal Intubation During Cardiopulmonary Resuscitation (CPR)
- ClinicalTrials.gov ID
- NCT04114721
- Acronym / sponsor ID
- CPRintuexperience_VL
- Conditions
- Cardiopulmonary Arrest
- Keywords
- intubation, cardiopulmonary resuscitation, Learning curve, videolaryngoscope
- 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
- 3 Oct 2019 (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 study based on analysis of video-clip data of endotracheal intubation (ETI) using videolaryngoscope (VL) and clinical data for cardiopulmonary resuscitation patients between 2012.03.01.-2015.02.28.
The purpose of this study is to evaluate the appropriate numbers of VL usages for successful ETI at first attempt during cardiopulmonary resuscitation.
Detailed description
Direct layngoscope (DL) is a basic tool for endotracheal intubation(ETI) during cardiopulmonary resuscitation(CPR). ETI during CPR has higher risks of failure or delayed success with frequent attempts, misplacement of the tube, and prolonged interruptions of chest compressions. The main problems associated with ETI relate to the inherently technical difficulty in using DL. VL have various advantages of fast learning curve and overall success comparing with the DL in non-arrest patients, but there was no known data of learnig curve of successful ETI during CPR.
This study tried to estimate the the appropriate numbers of VL usage for successful ETI at first attempt during CPR. So the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of ETI using VL which in real clinical setting. In addition, this study analyze the residency training term, total number of of VL usage using VL at that time.
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 and physician tried ti intubate using viseolaryngoscope.
Key exclusion criteria (3 listed)
- case of requesting the do-not-attempt resuscitation befor ETI
- intubated cases before arrival to emergency department
- physician tried ti intubate using direct-laryngoscope
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
YES or No of successful intubation without complication
Time frame: successful endotracheal intubation with in 60 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 31 Oct 2019.
- Background: PubMed 30025947Dagli R, Canturk M, Celik F, Erbesler ZA, Gurler M. [The role of videolaryngoscope in endotracheal intubation training programs]. Braz J Anesthesiol. 2018 Sep-Oct;68(5):447-454. doi: 10.1016/j.bjan.2018.02.008. Epub 2018 Jul 17.
- Background: PubMed 25922892Bernhard M, Benger JR. Airway management during cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):183-7. doi: 10.1097/MCC.0000000000000201.
- Background: PubMed 26711127Buis ML, Maissan IM, Hoeks SE, Klimek M, Stolker RJ. Defining the learning curve for endotracheal intubation using direct laryngoscopy: A systematic review. Resuscitation. 2016 Feb;99:63-71. doi: 10.1016/j.resuscitation.2015.11.005. Epub 2015 Dec 19.
- Results publication: PubMed 23541527Park SO, Baek KJ, Hong DY, Kim SC, Lee KR. Feasibility of the video-laryngoscope (GlideScope(R)) for endotracheal intubation during uninterrupted chest compressions in actual advanced life support: a clinical observational study in an urban emergency department. Resuscitation. 2013 Sep;84(9):1233-7. doi: 10.1016/j.resuscitation.2013.03.026. Epub 2013 Mar 26.
- Individual participant dataSharing planned: No
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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 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 31 Oct 2019. 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?
YES or No of successful intubation without complication (time frame: successful endotracheal intubation with in 60 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 NCT04114721, 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 31 Oct 2019.