Difficult IntubationNCT02478203
Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope
A study testing Airtraq, Glidescope and direct laryngoscopy in people with Difficult Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Airtraq, Glidescope and direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Jul 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric
Who cannot join
- adult
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine
Kocaeli, 41900
About this study
Official title: Intubation on a Pediatric Manikin by Emergency Medical Staff: a Comparison of Direct Laryngoscopy, Airtraq and Glidescope in Normal, Tongue Edema and Face-to-face Intubation Models
After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models.
Read the detailed description
After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq , Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models; normal airway, tongue edema and an entrapped model by face-to-face approach. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and the need for maneuvers of these devices were recorded.
- Conditions
- Difficult Intubation
- Being tested
- Airtraq, Glidescope, direct laryngoscopy
- Keywords
- Airtraq, Glidescope, pediatric, face-to-face
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
videolaryngoscope for difficult airway
GlidescopeDevice
videolaryngoscope for difficult airway
direct laryngoscopyDevice
gold standart for intubation
| Study group | Role | What they receive |
|---|---|---|
| normal | Placebo comparator | intubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope Receives: Device: Airtraq; Device: Glidescope; Device: direct laryngoscopy |
| tongue edema | Active comparator | intubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq Receives: Device: Airtraq; Device: Glidescope; Device: direct laryngoscopy |
| face-to-face intubation | Active comparator | intubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq Receives: Device: Airtraq; Device: Glidescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
handling of the device till visualization of the tube entering through the vocal cords
Measured: 120 seconds
Secondary outcomes (5)
need of maneuvers (mender applied or not)
maneuver applied or not
Measured: intraoperative
esophageal intubation (eosophageal intubation occured or not)
eosophageal intubation occured or not
Measured: intraoperative
intubation attempts (is it increased or not)
the patient intubated at which attempt?
Measured: intraoperative
cormack-lehane grade (which one improves the cormack- lehane grade)
Measured: intraoperative
insertion time
handling of the device till the glottic visualization
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
- Investigators
- Zehra I Arslan, Study director, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478203
- Sponsor's protocol ID
- KOU KAEK 2014/108
- Status last verified
- Feb 2017
- First submitted
- 17 Apr 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation on a Pediatric Manikin by Emergency Medical Staff: a Comparison of Direct Laryngoscopy, Airtraq and Glidescope in Normal, Tongue Edema and Face-to-face Intubation Models
- ClinicalTrials.gov ID
- NCT02478203
- Acronym / sponsor ID
- KOU KAEK 2014/108
- Conditions
- Difficult Intubation
- Keywords
- Airtraq, Glidescope, pediatric, face-to-face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jun 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.
After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models.
Detailed description
After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq , Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models; normal airway, tongue edema and an entrapped model by face-to-face approach. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and the need for maneuvers of these devices were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal | Placebo comparator | Device: Airtraq, Device: Glidescope, Device: direct laryngoscopyintubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope |
| tongue edema | Active comparator | Device: Airtraq, Device: Glidescope, Device: direct laryngoscopyintubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq |
| face-to-face intubation | Active comparator | Device: Airtraq, Device: Glidescopeintubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric
Key exclusion criteria (1 listed)
- adult
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 |
|---|---|---|
| Airtraqvideolaryngoscope for difficult airway | Device | face-to-face intubation, normal, tongue edema |
| Glidescopevideolaryngoscope for difficult airway | Device | face-to-face intubation, normal, tongue edema |
| direct laryngoscopygold standart for intubation | Device | normal, tongue edema |
Primary outcome
intubation time
Time frame: 120 seconds
handling of the device till visualization of the tube entering through the vocal cords
5 secondary outcomes
need of maneuvers (mender applied or not)
Time frame: intraoperative
esophageal intubation (eosophageal intubation occured or not)
Time frame: intraoperative
intubation attempts (is it increased or not)
Time frame: intraoperative
cormack-lehane grade (which one improves the cormack- lehane grade)
Time frame: intraoperative
insertion time
Time frame: 30 seconds
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 3 Feb 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.
Zehra I Arslan study director
Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airtraq, Glidescope and direct laryngoscopy in people with Difficult Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 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 3 Feb 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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: 120 seconds). 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 3 Feb 2017.