Heart Arresti-gel_brNCT02411422
Comparison of Efficiency Between I-gel Blind Intubation and I-gel Bronchoscopic Intubation During Resuscitation
A study testing Conventional endotracheal tube and Reinforced endotracheal tube in people with Heart Arrest, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The investigators will compare conventional intubation using Macintosh laryngoscope, blind endotracheal intubation using i-gel for conduit and bronchoscopic intubation using Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest compressions continuously without interruption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Conventional endotracheal tube and Reinforced endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Apr 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
- emergency physician
- work at emergency department more than 1 year.
- 50 or more experience of endotracheal intubation
Who cannot join
- having backache or wrist pain
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam Sacred Heart Hospital
Seoul, Yeongdeungpo-gu, 150-037
About this study
Official title: Comparison of Efficiency Between I-gel-Assisted Blind Intubation and I-gel-assisted Bronchoscopic Intubation During Cardiopulmonary Resuscitation: Randomized Simulation Study
The investigators will compare conventional intubation using Macintosh laryngoscope, blind endotracheal intubation using i-gel for conduit and bronchoscopic intubation using Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest compressions continuously without interruption.
Moreover the investigators will compare the type of endotracheal tube. Reinforced tube has more soft tube tip, so the investigators think it is more acceptable for intubation using i-gel as conduit.
- Conditions
- Heart Arrest
- Being tested
- Conventional endotracheal tube, Reinforced endotracheal tube
- Keywords
- intubation, cardiopulmonary resuscitation, manikins
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional endotracheal tubeDevice
Conventional endotracheal tube
Reinforced endotracheal tubeDevice
Reinforced endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Intubation using laryngoscope | Experimental | Intubation using Macintosh laryngoscope. we will check procedure time according to kind of endotracheal tube, separately.
Two kinds of endotracheal tube will be used
* Conventional endotracheal tube
* Reinforced endotracheal tube Receives: Device: Conventional endotracheal tube; Device: Reinforced endotracheal tube |
| i-gel blind intubation | Experimental | i-gel blind intubation means that blind endotracheal intubation will be performed after i-gel insertion.
i-gel will be used as a conduit. we will check procedure time according to kind of endotracheal tube, separately.
Two kinds of endotracheal tube will be used
* Conventional endotracheal tube
* Reinforced endotracheal tube Receives: Device: Conventional endotracheal tube; Device: Reinforced endotracheal tube |
| i-gel bronchoscopic intubation | Experimental | i-gel bronchoscopic intubation means that bronchoscopic endotracheal intubation will be performed after i-gel insertion.
i-gel will be used as a conduit. we will check procedure time according to kind of endotracheal tube, separately.
Two kinds of endotracheal tube will be used
* Conventional endotracheal tube
* Reinforced endotracheal tube Receives: Device: Conventional endotracheal tube; Device: Reinforced endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
1st intubation attempt, an expected average time is 1 min.
Measured: 1 Day
Secondary outcomes (1)
success rate for intubation
the rate for successful 1st intubation
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi Hyun Young, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411422
- Sponsor's protocol ID
- 2015-02-30
- Acronym
- i-gel_br
- Status last verified
- Apr 2015
- First submitted
- 18 Mar 2015
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficiency Between I-gel-Assisted Blind Intubation and I-gel-assisted Bronchoscopic Intubation During Cardiopulmonary Resuscitation: Randomized Simulation Study
- ClinicalTrials.gov ID
- NCT02411422
- Acronym / sponsor ID
- i-gel_br / 2015-02-30
- Conditions
- Heart Arrest
- Keywords
- intubation, cardiopulmonary resuscitation, manikins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Apr 2015 (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.
The investigators will compare conventional intubation using Macintosh laryngoscope, blind endotracheal intubation using i-gel for conduit and bronchoscopic intubation using Ambu-aScope and i-gel. All situation assumed as cardiac arrest. i.e, someone give chest compressions continuously without interruption.
Moreover the investigators will compare the type of endotracheal tube. Reinforced tube has more soft tube tip, so the investigators think it is more acceptable for intubation using i-gel as conduit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubation using laryngoscope | Experimental | Device: Conventional endotracheal tube, Device: Reinforced endotracheal tubeIntubation using Macintosh laryngoscope. we will check procedure time according to kind of endotracheal tube, separately. Two kinds of endotracheal tube will be used * Conventional endotracheal tube * Reinforced endotracheal tube |
| i-gel blind intubation | Experimental | Device: Conventional endotracheal tube, Device: Reinforced endotracheal tubei-gel blind intubation means that blind endotracheal intubation will be performed after i-gel insertion. i-gel will be used as a conduit. we will check procedure time according to kind of endotracheal tube, separately. Two kinds of endotracheal tube will be used * Conventional endotracheal tube * Reinforced endotracheal tube |
| i-gel bronchoscopic intubation | Experimental | Device: Conventional endotracheal tube, Device: Reinforced endotracheal tubei-gel bronchoscopic intubation means that bronchoscopic endotracheal intubation will be performed after i-gel insertion. i-gel will be used as a conduit. we will check procedure time according to kind of endotracheal tube, separately. Two kinds of endotracheal tube will be used * Conventional endotracheal tube * Reinforced endotracheal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- emergency physician
- work at emergency department more than 1 year.
- 50 or more experience of endotracheal intubation
Key exclusion criteria (1 listed)
- having backache or wrist pain
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 |
|---|---|---|
| Conventional endotracheal tubeConventional endotracheal tube | Device | Intubation using laryngoscope, i-gel blind intubation, i-gel bronchoscopic intubation |
| Reinforced endotracheal tubeReinforced endotracheal tube | Device | Intubation using laryngoscope, i-gel blind intubation, i-gel bronchoscopic intubation |
Primary outcome
intubation time
Time frame: 1 Day
1st intubation attempt, an expected average time is 1 min.
1 secondary outcome
success rate for intubation
Time frame: 1 Day
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 14 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional endotracheal tube and Reinforced endotracheal tube in people with Heart Arrest, run by Hallym University Kangnam Sacred Heart 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 3 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 14 Apr 2015. 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?
intubation time (time frame: 1 Day). 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 14 Apr 2015.