ObesityNCT03597880
Preoperative Evaluation of Airway
A study testing obese patients in people with Obesity and Difficult Intubation, run by Yeditepe University Hospital.
Trial summary
Evaluation of airway markers of patients who have undergone obesity surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Difficult Intubation
- What is being tested?
- obese patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 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
- BMI>30kg/m2
- 18<age <65
- elective surgery planned
- ASA II-III
Who cannot join
- BMI<30kg/m2
- 18>age >65
- ASA IV
About this study
Official title: Evaluation of Airway on Undervent Bariatric Surgery Patients
Evaluation of airway markers of patients who have undergone obesity surgery.
Read the detailed description
The investigators evaluated the airway parameters recorded preoperatively for patients with BMI> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.
- Conditions
- Obesity, Difficult Intubation
- Being tested
- obese patients
- Keywords
- difficult airway, obese patient,
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obese patientsOther
underwent bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| obese patient | Other | BMI>30 kg/m2 and underwent bariatric surgery Receives: Other: obese patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway evaluation for menagement in obese patient
preoperative airway measurements routinely performed (mallampati score, thyromental distance, neck circumference ..)for each patient will be evaluated
Measured: 3 year
mallampati score
Class I : Visualization of the soft palate, fauces; uvula, anterior and the posterior pillars. Class II : Visualization of the soft palate, fauces and uvula. Class III : Visualization of soft palate and base of uvula. Class IV: Only hard palate is visible. Soft palate is not visible at all.
Measured: 3 year
thyromental distance
TMD was measured as straight distance between thyroid notch and lower border of mental prominence.(cm)
Measured: 3 year
neck circumference
Neck Circumference was measured in the midway of the neck, between mid-cervical spine and mid anterior neck, to within 1 mm, using non-stretchable plastic tape with the subjects standing upright.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Screening
- Intervention model
- Sequential
- Model description
- retrospective clinical trial
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nurcan kizilcik, Yeditepe University Hospital
- Investigators
- nurcan kizilcik, Principal investigator, Yeditepe UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597880
- Sponsor's protocol ID
- YeditepeUH
- Status last verified
- Jul 2018
- First submitted
- 16 May 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For the protection of personal data, was decided that the personal data of the participants should not be shared .
Publications
Langeron O, Birenbaum A, Le Sache F, Raux M. Airway management in obese patient. Minerva Anestesiol. 2014 Mar;80(3):382-92. Epub 2013 Oct 14.
PubMed 24122033
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Airway on Undervent Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03597880
- Acronym / sponsor ID
- YeditepeUH
- Conditions
- Obesity, Difficult Intubation
- Keywords
- difficult airway, obese patient,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 24 Jul 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.
Evaluation of airway markers of patients who have undergone obesity surgery.
Detailed description
The investigators evaluated the airway parameters recorded preoperatively for patients with BMI> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.
Study design
- Primary purpose
- Screening
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- retrospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| obese patient | Other | Other: obese patientsBMI>30 kg/m2 and underwent bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI>30kg/m2
- 18<age <65
- elective surgery planned
- ASA II-III
Key exclusion criteria (3 listed)
- BMI<30kg/m2
- 18>age >65
- ASA IV
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 |
|---|---|---|
| obese patientsunderwent bariatric surgery | Other | obese patient |
Primary outcome
airway evaluation for menagement in obese patient
Time frame: 3 year
preoperative airway measurements routinely performed (mallampati score, thyromental distance, neck circumference ..)for each patient will be evaluated
mallampati score
Time frame: 3 year
Class I : Visualization of the soft palate, fauces; uvula, anterior and the posterior pillars. Class II : Visualization of the soft palate, fauces and uvula. Class III : Visualization of soft palate and base of uvula. Class IV: Only hard palate is visible. Soft palate is not visible at all.
thyromental distance
Time frame: 3 year
TMD was measured as straight distance between thyroid notch and lower border of mental prominence.(cm)
neck circumference
Time frame: 3 year
Neck Circumference was measured in the midway of the neck, between mid-cervical spine and mid anterior neck, to within 1 mm, using non-stretchable plastic tape with the subjects standing upright.
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 24 Jul 2018.
- Results publication: PubMed 24122033Langeron O, Birenbaum A, Le Sache F, Raux M. Airway management in obese patient. Minerva Anestesiol. 2014 Mar;80(3):382-92. Epub 2013 Oct 14.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. For the protection of personal data, was decided that the personal data of the participants should not be shared .
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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.
nurcan kizilcik principal investigator
Yeditepe UH
Questions about this trial
What is this clinical trial studying?
A study testing obese patients in people with Obesity and Difficult Intubation, run by Yeditepe University Hospital.
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 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 24 Jul 2018. 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.
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?
airway evaluation for menagement in obese patient (time frame: 3 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597880, which also lists 1 linked publication.
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 24 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.