Obesity, MorbidNCT05927519
Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study
A study testing airtraq video laryngoscope in people with Obesity, Morbid and Intubation; Difficult or Failed, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Obesity, Morbid, Intubation; Difficult or Failed, Video Laryngoscope
- What is being tested?
- airtraq video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 5 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Kocaeli University Medical Faculty Hospital
Iamit, 41100
- Active, not recruiting
Kocaeli UniversityMedical Faculty
Kocaeli, 41100
About this study
Official title: Airtraq in Obese and Nonobese Men
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, perioperative hemodynamic variables, and postoperative complications will also be recorded.
Read the detailed description
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, need of optimization menuvers, perioperative hemodynamic variables, and postoperative complications will also be recorded.
- Being tested
- airtraq video laryngoscope
- Medical subject headings
- Obesity, Morbid, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airtraq video laryngoscopeDevice
airtraq video laryngoscope will be used for intubations
| Study group | Role | What they receive |
|---|---|---|
| morbidly obese | Active comparator | Class 2 (bmı >35) weight kg/height m2 and class 3 (bmı>40) obese men Receives: Device: airtraq video laryngoscope |
| nonobese | Placebo comparator | bmı<30 weight kg/ height m2 men Receives: Device: airtraq video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
the intubation time will be recorded beginning the insertion of the Airtraq through the mouth still the endotracheal tube seen passing through the vocal cords
Measured: 50 seconds
Secondary outcomes (2)
insertion time
inserting the Airtraq through the mouth till the optimal glottic vizualization occurred
Measured: 20 seconds
peroperative hemodynamic variable
heart rate
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start25 Oct 2024
- Primary completion5 Oct 2027 (estimated)
- Study completion5 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Model description
- Airtraq video laryngoscope will be used in morbid obese and non obese patients
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927519
- Sponsor's protocol ID
- KAEK/10.bI.03
- Status last verified
- Oct 2024
- First submitted
- 19 Jun 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airtraq in Obese and Nonobese Men
- ClinicalTrials.gov ID
- NCT05927519
- Acronym / sponsor ID
- KAEK/10.bI.03
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 5 Oct 2027 (estimated)
- Study completion
- 5 Oct 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- 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.
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, perioperative hemodynamic variables, and postoperative complications will also be recorded.
Detailed description
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, need of optimization menuvers, perioperative hemodynamic variables, and postoperative complications will also be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Airtraq video laryngoscope will be used in morbid obese and non obese patients
| Arm | Type | Receives |
|---|---|---|
| morbidly obese | Active comparator | Device: airtraq video laryngoscopeClass 2 (bmı >35) weight kg/height m2 and class 3 (bmı>40) obese men |
| nonobese | Placebo comparator | Device: airtraq video laryngoscopebmı<30 weight kg/ height m2 men |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| airtraq video laryngoscopeairtraq video laryngoscope will be used for intubations | Device | morbidly obese, nonobese |
Primary outcome
intubation time
Time frame: 50 seconds
the intubation time will be recorded beginning the insertion of the Airtraq through the mouth still the endotracheal tube seen passing through the vocal cords
2 secondary outcomes
insertion time
Time frame: 20 seconds
peroperative hemodynamic variable
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing airtraq video laryngoscope in people with Obesity, Morbid and Intubation; Difficult or Failed, run by Kocaeli University at 2 sites 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 0 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: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zehra Arslan, professor (00902623038168, zehraipek48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation time (time frame: 50 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 28 Oct 2024.