Obesity, MorbidNCT03759990
Tracheal Intubation in Morbidly Obese (BMI>35) and in Lean (BMI<30) Patients Using McGrath MAC X-Blade
A study testing lean and obese in people with Obesity, Morbid, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- lean and obese
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 1 Dec 2018
- 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
- bmı 35
- undergoing elective surgery requiring endotracheal intubation
Who cannot join
- <18 and >65 years of age
- bmı<35
- upper respiratory tract infection past ten days
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kocaeli University School of Medicine
Kocaeli, 41900
Kocaeli University Medical Faculty
Kocaeli
About this study
Official title: A Comparison of Morbidly Obese and Lean
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative complications were recorded.
Read the detailed description
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients were recorded. Airway management variables Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers ( cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness were recorded.
- Conditions
- Obesity, Morbid
- Being tested
- lean, obese
- Keywords
- videolaryngoscope, Airtraq, McGrath MAC, Morbid obesity, intubation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leanDevice
Videolaryngoscope used in intubation
obeseDevice
Videolaryngoscope used in intubation
| Study group | Role | What they receive |
|---|---|---|
| insertion time | Active comparator | Not described Receives: Device: lean; Device: obese |
| intubation time | Active comparator | Not described Receives: Device: lean; Device: obese |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Aug 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759990
- Sponsor's protocol ID
- KOU-KAEK 2018 - 202
- Status last verified
- Mar 2020
- First submitted
- 29 Nov 2018
- Last updated
- 4 Mar 2020
- 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Morbidly Obese and Lean
- ClinicalTrials.gov ID
- NCT03759990
- Acronym / sponsor ID
- KOU-KAEK 2018 - 202
- Conditions
- Obesity, Morbid
- Keywords
- videolaryngoscope, Airtraq, McGrath MAC, Morbid obesity, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 30 Nov 2018 (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.
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative complications were recorded.
Detailed description
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients were recorded. Airway management variables Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers ( cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insertion time | Active comparator | Device: lean, Device: obese |
| intubation time | Active comparator | Device: lean, Device: obese |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bmı 35
Key exclusion criteria (3 listed)
- <18 and >65 years of age
- bmı<35
- upper respiratory tract infection past ten days
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 |
|---|---|---|
| leanVideolaryngoscope used in intubation | Device | insertion time, intubation time |
| obeseVideolaryngoscope used in intubation | Device | insertion time, intubation time |
Primary outcome
intubation time
Time frame: 2 months
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 4 Mar 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lean and obese in people with Obesity, Morbid, 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 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 4 Mar 2020. 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. 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: 2 months). 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 4 Mar 2020.