Intubation DifficultPhase 4NCT02286570
Face-to-face Tracheal Intubation: a Comparison of Airtraq, Glidescope and Fastrach
A Phase 4 study testing Glidescope, Airtraq and Fastrach in people with Intubation Difficult, run by Kocaeli University.
Trial summary
Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation Difficult
- What is being tested?
- Glidescope, Airtraq and Fastrach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age
- Elective surgery requiring endotracheal intubation
- Normal airway variables
- BMI< 30
Who cannot join
- < 18 years or > 60 years
- Emergency procedures
- Known difficult airways
- BMI> 30
About this study
Official title: Face-to-face Tracheal Intubation With Fastrach or Videolaryngoscopes
Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.
Read the detailed description
The investigators record the demographic and the airway data of the patients (thyromental distance, sternomental distance, mallampati score, mandibula protrusions, interincisor distance..etc). The hemodynamic data of the patients baseline preoperatively, after induction, after insertion of the device, after intubation, and 2 minutes intervals after intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue damage, postoperative sore throat, hoarseness, dysphagia were recorded.
- Conditions
- Intubation Difficult
- Being tested
- Glidescope, Airtraq, Fastrach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlidescopeDevice
videolaryngoscope used for endotracheal intubation
AirtraqDevice
videolaryngoscope used for endotracheal intubation
FastrachDevice
intubating laryngeal mask airway used for blind endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| face-to-face intubation of Glidescope | Active comparator | patients were intubated using glidescope by face-to-face approach Receives: Device: Glidescope |
| face-to-face intubation with Airtraq | Active comparator | patients were intubated using the Airtraq by face-to-face approach Receives: Device: Airtraq |
| face-to-face intubation with fastrach | Active comparator | patients were intubated using the Fastrach by face-to-face approach Receives: Device: Fastrach |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
2 minutes
Measured: elapsing between the handling of the device till intubation 2 minutes
Secondary outcomes (4)
mucosal damage
1 minute after removal
Measured: blood on the device after removal 1 minute
postoperative minor complications sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia
30 minutes after extubation
Measured: sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia 30 minutes
need of optimisation maneuvers
during 15 minutes while intubation
Measured: chandy, side-to-side, handling force, up-down, reinserting 15 minutes
hemodynamic changes (mean arteriial pressure)
mmHg
Measured: entübation and after 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 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
- 120 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
- NCT02286570
- Sponsor's protocol ID
- KOU KAEK 2014/255
- 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 Tracheal Intubation With Fastrach or Videolaryngoscopes
- ClinicalTrials.gov ID
- NCT02286570
- Acronym / sponsor ID
- KOU KAEK 2014/255
- Conditions
- Intubation Difficult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 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.
Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.
Detailed description
The investigators record the demographic and the airway data of the patients (thyromental distance, sternomental distance, mallampati score, mandibula protrusions, interincisor distance..etc). The hemodynamic data of the patients baseline preoperatively, after induction, after insertion of the device, after intubation, and 2 minutes intervals after intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue damage, postoperative sore throat, hoarseness, dysphagia were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| face-to-face intubation of Glidescope | Active comparator | Device: Glidescopepatients were intubated using glidescope by face-to-face approach |
| face-to-face intubation with Airtraq | Active comparator | Device: Airtraqpatients were intubated using the Airtraq by face-to-face approach |
| face-to-face intubation with fastrach | Active comparator | Device: Fastrachpatients were intubated using the Fastrach by face-to-face approach |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-60 years of age
- Elective surgery requiring endotracheal intubation
- Normal airway variables
- BMI< 30
Key exclusion criteria (4 listed)
- < 18 years or > 60 years
- Emergency procedures
- Known difficult airways
- BMI> 30
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 |
|---|---|---|
| Glidescopevideolaryngoscope used for endotracheal intubation | Device | face-to-face intubation of Glidescope |
| Airtraqvideolaryngoscope used for endotracheal intubation | Device | face-to-face intubation with Airtraq |
| Fastrachintubating laryngeal mask airway used for blind endotracheal intubation | Device | face-to-face intubation with fastrach |
Primary outcome
intubation time
Time frame: elapsing between the handling of the device till intubation 2 minutes
2 minutes
4 secondary outcomes
mucosal damage
Time frame: blood on the device after removal 1 minute
postoperative minor complications sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia
Time frame: sore troat, teeth damage, tongue damage, desaturation, hoarseness, disphagia 30 minutes
need of optimisation maneuvers
Time frame: chandy, side-to-side, handling force, up-down, reinserting 15 minutes
hemodynamic changes (mean arteriial pressure)
Time frame: entübation and after 15 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, Airtraq and Fastrach in people with Intubation Difficult, 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 4 inclusion and 4 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 time (time frame: elapsing between the handling of the device till intubation 2 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.