Intubation; DifficultPhase 4NCT02290249
Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq
A Phase 4 study testing Glidescope and Airtraq in people with Intubation; Difficult and Edema of the Tongue, run by Kocaeli University.
Trial summary
Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult, Edema of the Tongue
- What is being tested?
- Glidescope and Airtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jan 2015
- Phase
- Phase 4
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- medical students at their third year,
- novice personnel
Who cannot join
- anesthesists,
- anesthesia residents,
- skilled investigators of tracheal intubation
About this study
Official title: Face-to-face Intubation With Glidescope or Airtraq
Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal.
Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.
Read the detailed description
Trauma victims mostly had to be intubated at the scene of the area with the paramedics. In a suspect of a cervical trauma, patients must be intubated with the least movement. Videolaryngoscopic techniques had several advantages at this condition. We want to investigate which can be used easily by novice personnel.
- Conditions
- Intubation; Difficult, Edema of the Tongue
- Being tested
- Glidescope, Airtraq
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlidescopeDevice
Manikin was intubated by different novice personal with glidescope videolaryngoscope
AirtraqDevice
Pediatric manikin was intubated by novice personal with airtraq
| Study group | Role | What they receive |
|---|---|---|
| normal airway | Active comparator | İntubation with glidescope or airtraq in normal airway Receives: Device: Glidescope; Device: Airtraq |
| tongue edema | Active comparator | intubation with glidescope or airtraq in tongue edema simulation Receives: Device: Glidescope; Device: Airtraq |
| face-to-face | Active comparator | intubation with glidescope or airtraq in face-to-face intubation Receives: Device: Glidescope; Device: Airtraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation success rates
We recorded the first and total intubation success rates of the intubation with one of these devices
Measured: 5 minutes
Secondary outcomes (3)
intubation time
from the handling of the device till viewing the endotracheal tube entering the vocal cords
Measured: 5 minutes
Esophageal intubation
is there an esophageal intubation occurred while inserting the tube or not
Measured: 5 minutes
need of optimisation maneuvers
do we need an optimization maneuver while intubating or while viewing the glottis or not
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; DifficultStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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, Doctor, Principal investigator, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290249
- Sponsor's protocol ID
- KOU KAEK 2014/145
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face-to-face Intubation With Glidescope or Airtraq
- ClinicalTrials.gov ID
- NCT02290249
- Acronym / sponsor ID
- KOU KAEK 2014/145
- Conditions
- Intubation; Difficult, Edema of the Tongue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Nov 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.
Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal.
Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.
Detailed description
Trauma victims mostly had to be intubated at the scene of the area with the paramedics. In a suspect of a cervical trauma, patients must be intubated with the least movement. Videolaryngoscopic techniques had several advantages at this condition. We want to investigate which can be used easily by novice personnel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal airway | Active comparator | Device: Glidescope, Device: Airtraqİntubation with glidescope or airtraq in normal airway |
| tongue edema | Active comparator | Device: Glidescope, Device: Airtraqintubation with glidescope or airtraq in tongue edema simulation |
| face-to-face | Active comparator | Device: Glidescope, Device: Airtraqintubation with glidescope or airtraq in face-to-face intubation |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- medical students at their third year,
- novice personnel
Key exclusion criteria (3 listed)
- anesthesists,
- anesthesia residents,
- skilled investigators of tracheal intubation
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 |
|---|---|---|
| GlidescopeManikin was intubated by different novice personal with glidescope videolaryngoscope | Device | face-to-face, normal airway, tongue edema |
| AirtraqPediatric manikin was intubated by novice personal with airtraq | Device | face-to-face, normal airway, tongue edema |
Primary outcome
intubation success rates
Time frame: 5 minutes
We recorded the first and total intubation success rates of the intubation with one of these devices
3 secondary outcomes
intubation time
Time frame: 5 minutes
Esophageal intubation
Time frame: 5 minutes
need of optimisation maneuvers
Time frame: 5 minutes
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 1 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.
Zehra I ARSLAN, Doctor principal investigator
Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glidescope and Airtraq in people with Intubation; Difficult and Edema of the Tongue, run by Kocaeli University.
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 1 Apr 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 success rates (time frame: 5 minutes). 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 1 Apr 2015.