Cardiac ArrestNCT02074072
Endotracheal Intubation Using Three Laryngoscopes in Maternal Cardiac Arrest: a Manikin Simulation Study
A study testing 15 degree left-lateral tilt wedges and 30 degree left-lateral tilt wedges in people with Cardiac Arrest, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality chest compressions .They propose minor changes for pregnant women: manual left deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- 15 degree left-lateral tilt wedges and 30 degree left-lateral tilt wedges
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Mar 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experience of intubation > 50 times
- Postgraduates year 1,2,3,4 and Emergency physicians in emergency department
Who cannot join
- Wrist or Low back disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Glidescope, Pentax-AWS and Macintosh Laryngoscope for Intubation During Chest Compression in 15-30 Degree Left-Lateral Tilt: A Manikin Simulation Study of Maternal Cardiopulmonary Resuscitation
European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality chest compressions .They propose minor changes for pregnant women: manual left deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava. We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30 degree left-lateral tilt (15 \&30 LLT) custom-made hard wedges.
Read the detailed description
Materials
- Sim Mom manikin (Laerdal, Stavanger, Norway)
- Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US)
- LUCAS Chest Compression System( LUCAS Chest Compression System, Physio-Control/Jolife AB)
- Backboard(450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea)
- Conditions
- Cardiac Arrest
- Being tested
- 15 degree left-lateral tilt wedges, 30 degree left-lateral tilt wedges
- Keywords
- Endotracheal intubation, Left lateral tilt wedge, Maternal Cardiopulmonary Resuscitation, Manikin Study
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 degree left-lateral tilt wedgesDevice
Also called Custom-made hard wedges
The wedges are made of aluminium
30 degree left-lateral tilt wedgesDevice
Also called Custom-made hard wedges
The wedges are made of aluminium
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscope | Experimental | Macintosh laryngoscope Receives: Device: 15 degree left-lateral tilt wedges; Device: 30 degree left-lateral tilt wedges |
| Videolaryngoscope-1 | Experimental | Glidescope Receives: Device: 15 degree left-lateral tilt wedges; Device: 30 degree left-lateral tilt wedges |
| Videolaryngoscope-2 | Experimental | Airwayscope Receives: Device: 15 degree left-lateral tilt wedges; Device: 30 degree left-lateral tilt wedges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
We will check the times from inserting blade to mouth to exposing vocal cord and from exposing vocal cord to first ambu-bagging.
Measured: 1day
Success rate of intubation
Definition of failed intubation
- Time to intubation is longer than 90 seconds.
- Wrong placement of endotracheal tube (For example : Esophageal intubation etc.)
Measured: 1day
Secondary outcomes (2)
Laryngeal View during intubation
We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.
Measured: 1day
The preference for laryngoscopes
- The preference for laryngoscope regardless of tilting degree of wedges
- The preference for laryngoscope in 15 degree left-lateral tilt situation .
- The preference for laryngoscope in 30 degree left-lateral tilt situation . (Participants will select only 1 of 3 laryngoscopes and the preference will be displayed as histogram)
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Sang Hyun, Hanyang University Seoul Hospital
- Investigators
- Sang hyun Lee, M.D, Principal investigator, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074072
- Sponsor's protocol ID
- HYI-14-004-1
- Status last verified
- Mar 2014
- First submitted
- 25 Feb 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glidescope, Pentax-AWS and Macintosh Laryngoscope for Intubation During Chest Compression in 15-30 Degree Left-Lateral Tilt: A Manikin Simulation Study of Maternal Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT02074072
- Acronym / sponsor ID
- HYI-14-004-1
- Conditions
- Cardiac Arrest
- Keywords
- Endotracheal intubation, Left lateral tilt wedge, Maternal Cardiopulmonary Resuscitation, Manikin Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Feb 2014 (estimated)
- 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.
European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality chest compressions .They propose minor changes for pregnant women: manual left deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava. We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30 degree left-lateral tilt (15 \&30 LLT) custom-made hard wedges.
Detailed description
Materials
- Sim Mom manikin (Laerdal, Stavanger, Norway)
- Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US)
- LUCAS Chest Compression System( LUCAS Chest Compression System, Physio-Control/Jolife AB)
- Backboard(450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Direct laryngoscope | Experimental | Device: 15 degree left-lateral tilt wedges, Device: 30 degree left-lateral tilt wedgesMacintosh laryngoscope |
| Videolaryngoscope-1 | Experimental | Device: 15 degree left-lateral tilt wedges, Device: 30 degree left-lateral tilt wedgesGlidescope |
| Videolaryngoscope-2 | Experimental | Device: 15 degree left-lateral tilt wedges, Device: 30 degree left-lateral tilt wedgesAirwayscope |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Experience of intubation > 50 times
- Postgraduates year 1,2,3,4 and Emergency physicians in emergency department
Key exclusion criteria (1 listed)
- Wrist or Low back disease
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 |
|---|---|---|
| 15 degree left-lateral tilt wedgesAlso: Custom-made hard wedgesThe wedges are made of aluminium | Device | Direct laryngoscope, Videolaryngoscope-1, Videolaryngoscope-2 |
| 30 degree left-lateral tilt wedgesAlso: Custom-made hard wedgesThe wedges are made of aluminium | Device | Direct laryngoscope, Videolaryngoscope-1, Videolaryngoscope-2 |
Primary outcome
Time to intubation
Time frame: 1day
We will check the times from inserting blade to mouth to exposing vocal cord and from exposing vocal cord to first ambu-bagging.
Success rate of intubation
Time frame: 1day
Definition of failed intubation * Time to intubation is longer than 90 seconds. * Wrong placement of endotracheal tube (For example : Esophageal intubation etc.)
2 secondary outcomes
Laryngeal View during intubation
Time frame: 1day
The preference for laryngoscopes
Time frame: 1day
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 21 Mar 2014.
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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 hyun Lee, M.D principal investigator
Hanyang University Seoul Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 degree left-lateral tilt wedges and 30 degree left-lateral tilt wedges in people with Cardiac Arrest, run by Hanyang University Seoul Hospital 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 1 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 21 Mar 2014. 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?
Time to intubation (time frame: 1day). The study lists 2 primary outcomes in all. 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 21 Mar 2014.