Cardiopulmonary ArrestNCT03256019
Compare Outcomes of CPR Between the Video-laryngoscopy (VL) Users and the Direct-laryngoscopy (DL) Users
A study testing Endotracheal Intubation in people with Cardiopulmonary Arrest, run by Konkuk University Medical Center.
Trial summary
This is a clinical study based on the analysis of video-clip data of cardiopulmonary resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between 2011 and 2015. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- Endotracheal Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 1 Mar 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patients who suffer sudden out-of hospital cardiac arrest
Who cannot join
- Cardiac arrests from multiple trauma
- Cases of requesting the do-not attempt resuscitation before ETI
- Intubated cases before arrival to emergency department
About this study
Official title: Improvement of Recovery of Spontaneous Circulation and Survival Using the Video-laryngoscopy for out-of Hospital Cardiac Arrest Patient
This is a clinical study based on the analysis of video-clip data of cardiopulmonary resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between 2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.
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 is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices using micro-camera technology have been designed to overcome the problems of DL.
This study tried to compare the recovery of spontaneous circulation (ROSC) and survival discharge between use of standard device (DL) and VL in a real clinical setting. In addition, this study also compare the first pass success rate of ETI,speed of ETI, incidences of complications, and chest compression interruptions during cardiopulmonary resuscitation between both device users.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- Endotracheal Intubation
- Keywords
- intubation, Cardiopulmonary Resuscitation
- 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
Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation
| Study group | Role | What they receive |
|---|---|---|
| DL user | Active comparator | Experienced emergency physicians who primarily used the direct laryngoscopy (DL) for endotracheal intubation during cardiopulmonary resuscitation. Receives: Procedure: Endotracheal Intubation |
| VL user | Active comparator | Experienced emergency physicians who primarily used the videolaryngoscopy (VL) for endotracheal intubation during cardiopulmonary resuscitation. Receives: Procedure: Endotracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with good neurologic outcome
Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)
Measured: 6 months after emergency department visit
Secondary outcomes (3)
ROSC
Recovery of spontaneous circulation by successful resuscitation
Measured: within 1 hour after emergency department visit
total time to complete ETI from the beginning
time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag
Measured: within 1 hour after emergency department visit
complication
Presence of chest compression interruption, esophageal intubation and dental injuries
Measured: within 1 hour after emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Mar 2011
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 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, M.D,Ph.D, Principal investigator, Department of Emergency Medicine, Konkuk University Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256019
- Sponsor's protocol ID
- CPRIntuVLvsDL
- Status last verified
- Dec 2017
- First submitted
- 17 Aug 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 26477701Hasegawa K, Hiraide A, Chang Y, Brown DF. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest. JAMA. 2013 Jan 16;309(3):257-66. doi: 10.1001/jama.2012.187612.
PubMed 23321764Wang 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 19573949Kaplan MB, Ward DS, Berci G. A new video laryngoscope-an aid to intubation and teaching. J Clin Anesth. 2002 Dec;14(8):620-6. doi: 10.1016/s0952-8180(02)00457-9.
PubMed 12565125Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.
PubMed 23101777
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Recovery of Spontaneous Circulation and Survival Using the Video-laryngoscopy for out-of Hospital Cardiac Arrest Patient
- ClinicalTrials.gov ID
- NCT03256019
- Acronym / sponsor ID
- CPRIntuVLvsDL
- Conditions
- Cardiopulmonary Arrest
- Keywords
- intubation, Cardiopulmonary Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 21 Aug 2017 (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 the analysis of video-clip data of cardiopulmonary resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between 2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.
Detailed description
Endotracheal intubation (ETI) has been considered to be the best method of airway management during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices using micro-camera technology have been designed to overcome the problems of DL.
This study tried to compare the recovery of spontaneous circulation (ROSC) and survival discharge between use of standard device (DL) and VL in a real clinical setting. In addition, this study also compare the first pass success rate of ETI,speed of ETI, incidences of complications, and chest compression interruptions during cardiopulmonary resuscitation between both device users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DL user | Active comparator | Procedure: Endotracheal IntubationExperienced emergency physicians who primarily used the direct laryngoscopy (DL) for endotracheal intubation during cardiopulmonary resuscitation. |
| VL user | Active comparator | Procedure: Endotracheal IntubationExperienced emergency physicians who primarily used the videolaryngoscopy (VL) for endotracheal intubation during cardiopulmonary resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who suffer sudden out-of hospital cardiac arrest
Key exclusion criteria (3 listed)
- Cardiac arrests from multiple trauma
- Cases of requesting the do-not attempt resuscitation before 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal IntubationInsertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation | Procedure or surgery | DL user, VL user |
Primary outcome
Survival with good neurologic outcome
Time frame: 6 months after emergency department visit
Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)
3 secondary outcomes
ROSC
Time frame: within 1 hour after emergency department visit
total time to complete ETI from the beginning
Time frame: within 1 hour after emergency department visit
complication
Time frame: within 1 hour after emergency department visit
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 Dec 2017.
- 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 23321764Hasegawa K, Hiraide A, Chang Y, Brown DF. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest. JAMA. 2013 Jan 16;309(3):257-66. doi: 10.1001/jama.2012.187612.
- 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 12565125Kaplan MB, Ward DS, Berci G. A new video laryngoscope-an aid to intubation and teaching. J Clin Anesth. 2002 Dec;14(8):620-6. doi: 10.1016/s0952-8180(02)00457-9.
- Background: PubMed 23101777Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.
- 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,Ph.D principal investigator
Department of Emergency Medicine, Konkuk University Medical center
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Intubation in people with Cardiopulmonary Arrest, run by Konkuk University Medical Center.
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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Survival with good neurologic outcome (time frame: 6 months after emergency department visit). 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 NCT03256019, which also lists 5 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 Dec 2017.