Intubation; Difficult or FailedNCT02969889
Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA
A study testing Airtraq and ILMA in people with Intubation; Difficult or Failed and Intubation Complication, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication
- What is being tested?
- Airtraq and ILMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Nov 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- BMI>35
Who cannot join
- patients have airway tumor
- patients undergoing head and neck surgery
- upper respiratory infection less than 10 days prior the surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine
Kocaeli, 41900
About this study
bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.
Read the detailed description
80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.
Divided into two groups ; Airtraq and ILMA .
BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this study.
patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade.
The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.
- Being tested
- Airtraq, ILMA
- Keywords
- Airtraq, Intubating laryngeal mask airway, BMI>35
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
video laryngoscope with a channel
ILMADevice
Also called intubating laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| intubation time | Active comparator | handling the device till the endotracheal tube passing through the glottis Receives: Device: Airtraq; Device: ILMA |
| insertion time | Active comparator | handling of the device till the glottic visualization Receives: Device: Airtraq; Device: ILMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
handling of the device till the endotracheal tube entering the glottis
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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 Arslan, Principal investigator, Kocaeli University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969889
- Sponsor's protocol ID
- KOU KAEK 2014/137
- Status last verified
- Feb 2017
- First submitted
- 18 Nov 2016
- 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 in Morbidly Obese: a Comparison of Airtraq and ILMA
- ClinicalTrials.gov ID
- NCT02969889
- Acronym / sponsor ID
- KOU KAEK 2014/137
- Keywords
- Airtraq, Intubating laryngeal mask airway, BMI>35
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Nov 2016 (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.
bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.
Detailed description
80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.
Divided into two groups ; Airtraq and ILMA .
BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this study.
patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade.
The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intubation time | Active comparator | Device: Airtraq, Device: ILMAhandling the device till the endotracheal tube passing through the glottis |
| insertion time | Active comparator | Device: Airtraq, Device: ILMAhandling of the device till the glottic visualization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- BMI>35
Key exclusion criteria (3 listed)
- patients have airway tumor
- patients undergoing head and neck surgery
- upper respiratory infection less than 10 days prior the surgery
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 |
|---|---|---|
| Airtraqvideo laryngoscope with a channel | Device | insertion time, intubation time |
| ILMAAlso: intubating laryngeal mask airway | Device | insertion time, intubation time |
Primary outcome
intubation time
Time frame: 1 minute
handling of the device till the endotracheal tube entering the glottis
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 Arslan principal investigator
Kocaeli University Medical Faculty
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 and ILMA in people with Intubation; Difficult or Failed and Intubation Complication, 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 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 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. 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 minute). 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.