Cardiopulmonary ArrestNCT03252886
Videolaryngoscopy During CPR for Trauma Patients
A study testing Endotracheal Intubation in people with Cardiopulmonary Arrest and Neck Injury Multiple, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest, Neck Injury Multiple
- 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
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2011to 1 Mar 2015
- 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
- Multiple trauma patients with suspected neck injuries
- Arrest Patients
Who cannot join
- Case of requesting the do-not attempt resuscitation before ETI
- already intubated case before arrival to hospital
- Cardiac arrest from non-traumatic causes
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: The Efficacy of Videolaryngoscopy During Cardiac-pulmonary Resuscitation (CPR) for Trauma Patients With Suspect Neck Injuries
This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy and direct- laryngoscopy users.
Read the detailed description
Endotracheal intubation (ETI) is 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. Especially, cervical immobilization by neck collar in truamatic patients is a great obstacle to successful ETI during CPR.
Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be more useful to perform ETI during CPR for trauma patients with cervical immobilization.
This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI, incidence of complications, and chest compression interruptions during cardiopulmonary resuscitation for trauma patients with suspected neck injury between intubators using the DL and the VL in a real clinical setting.
- Conditions
- Cardiopulmonary Arrest, Neck Injury Multiple
- Being tested
- Endotracheal Intubation
- Keywords
- intubation, Cardiopulmonary Resuscitation, neck injury
- Medical subject headings
- Heart Arrest, Neck Injuries
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 use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary resuscitation. Receives: Procedure: Endotracheal Intubation |
| VL user | Active comparator | Experienced emergency physicians who primarily use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary resuscitation. Receives: Procedure: Endotracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt successful ETI
Successfully insertion of endotracheal tube into trachea at first attempt
Measured: within 1 hour after emergency department visit
Secondary outcomes (2)
the time to complete ETI from the beginning
the 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
Occurance of 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 posted17 Aug 2017
- Study start1 Mar 2011
- Primary completion1 Mar 2015
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 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, School of Medicine, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252886
- Sponsor's protocol ID
- TRAUMACPRintu
- Status last verified
- Dec 2017
- First submitted
- 14 Aug 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- The Efficacy of Videolaryngoscopy During Cardiac-pulmonary Resuscitation (CPR) for Trauma Patients With Suspect Neck Injuries
- ClinicalTrials.gov ID
- NCT03252886
- Acronym / sponsor ID
- TRAUMACPRintu
- Conditions
- Cardiopulmonary Arrest, Neck Injury Multiple
- Keywords
- intubation, Cardiopulmonary Resuscitation, neck injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 17 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 collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy and direct- laryngoscopy users.
Detailed description
Endotracheal intubation (ETI) is 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. Especially, cervical immobilization by neck collar in truamatic patients is a great obstacle to successful ETI during CPR.
Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be more useful to perform ETI during CPR for trauma patients with cervical immobilization.
This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI, incidence of complications, and chest compression interruptions during cardiopulmonary resuscitation for trauma patients with suspected neck injury between intubators using the DL and the VL in a real clinical setting.
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 use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary resuscitation. |
| VL user | Active comparator | Procedure: Endotracheal IntubationExperienced emergency physicians who primarily use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Multiple trauma patients with suspected neck injuries
- Arrest Patients
Key exclusion criteria (3 listed)
- Case of requesting the do-not attempt resuscitation before ETI
- already intubated case before arrival to hospital
- Cardiac arrest from non-traumatic causes
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
First attempt successful ETI
Time frame: within 1 hour after emergency department visit
Successfully insertion of endotracheal tube into trachea at first attempt
2 secondary outcomes
the time to complete ETI from the beginning
Time frame: within 1 hour after emergency department visit
Occurance of 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.
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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
School of Medicine, Konkuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Intubation in people with Cardiopulmonary Arrest and Neck Injury Multiple, 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 2 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.
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?
First attempt successful ETI (time frame: within 1 hour after emergency department visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.