ObesityNCT05896098
Use of USG in Difficult Airway in Obese
An observational study of Obesity, run by Balikesir University at 2 sites in Turkey (Türkiye).
Trial summary
Introduction and Purpose: Obesity is an increasing public health problem all over the world. Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ultrasound
- How many people
- 2 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Aug 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: obese elective surgery patients
Who may be able to join
- Elective surgery, ages between 18-80 BMI over 30, ASA I-II
Who cannot join
- Facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Balikesir University
Balıkesir, 10145
Medical faculty
Balıkesir
About this study
Official title: Effectiveness of Ultrasonography for the Evaluation of Difficult Airway in Obese Patients.
Introduction and Purpose: Obesity is an increasing public health problem all over the world. Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. Obesity is frequently encountered in elective and emergency surgical procedures and causes more difficulties in airway management. Difficult airway, characterized by difficult mask ventilation and difficult intubation, is especially common in obese and morbidly obese patients. Some studies show that the measurement of anterior neck soft tissue thickness at the level of the vocal cords plays an important role in estimating difficult laryngoscopy in obese patients. Difficult intubation is envisaged in patients with pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the level of the vocal cord.
In this prospective observational study, it is aimed to measure the preoperative anterior cervical soft tissue thickness with 3 parameters by USG in obese patients undergoing elective surgery, and to evaluate the relationship of these values with the Han Scale and Cormack-Lehane classification and their effectiveness as an indicator of difficult airway.
Read the detailed description
Materials and Methods: 157 patients who will undergo elective surgery under general anesthesia, ages between 18-80, BMI ≥ 30 kg/m2, ASA I-II were included in the study. During the preoperative evaluation, patients' gender, age, height, weight, type of surgery, BMI, neck circumference, thyromental distance (TMM), sternomental distance (SMM), hyomental distance (HMM), neck extension, mouth opening and distance between incisors were measured and tooth structure was evaluated. OSAS was evaluated based on the ASA physical condition score and AHI. Mallampati Classification was recorded. Upper lip bite test was performed. Ultrasonographic measurements were made with the patient in the supine position and the head and neck in a neutral position. The Han Scale was used to evaluate difficult mask ventilation. The laryngoscopy image was evaluated and recorded with the Cormack-Lehane Classification, and ≥2b was accepted as difficult laryngoscopy.
- Conditions
- Obesity
- Being tested
- Ultrasound
- Keywords
- obesity ultrasound difficult airway
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Measurement of the airway by ultrasound in obese patients.
| Study group | Role | What they receive |
|---|---|---|
| Easy laryngoscopy | Cormack Lehane Classification 1-2a Receives: Other: Ultrasound | |
| Difficult laryngoscopy | Cormack Lehane Classification 2b-3-4 Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult laryngoscopy
To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.
Measured: preoperative evaluation
Secondary outcomes (1)
Difficult mask ventilation
To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.
Measured: preoperative evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Mar 2020
- Primary completion30 Mar 2022
- Study completion30 Aug 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan KOCAOGLU, Balikesir University
- Investigators
- Nazan Kocaoglu, Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896098
- Sponsor's protocol ID
- 2020/16
- Status last verified
- Jun 2023
- First submitted
- 10 May 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tasdemir O, Kocaoglu N, Demir HF, Ugun F, Sagir O. Ultrasound-based airway assessment in obese patients as a valuable tool for predicting difficult airway: an observational study. Braz J Anesthesiol. 2024 Nov-Dec;74(6):844539. doi: 10.1016/j.bjane.2024.844539. Epub 2024 Jul 10.
PubMed 38997064
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasonography for the Evaluation of Difficult Airway in Obese Patients.
- ClinicalTrials.gov ID
- NCT05896098
- Acronym / sponsor ID
- 2020/16
- Conditions
- Obesity
- Keywords
- obesity ultrasound difficult airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 9 Jun 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.
Introduction and Purpose: Obesity is an increasing public health problem all over the world. Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. Obesity is frequently encountered in elective and emergency surgical procedures and causes more difficulties in airway management. Difficult airway, characterized by difficult mask ventilation and difficult intubation, is especially common in obese and morbidly obese patients. Some studies show that the measurement of anterior neck soft tissue thickness at the level of the vocal cords plays an important role in estimating difficult laryngoscopy in obese patients. Difficult intubation is envisaged in patients with pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the level of the vocal cord.
In this prospective observational study, it is aimed to measure the preoperative anterior cervical soft tissue thickness with 3 parameters by USG in obese patients undergoing elective surgery, and to evaluate the relationship of these values with the Han Scale and Cormack-Lehane classification and their effectiveness as an indicator of difficult airway.
Detailed description
Materials and Methods: 157 patients who will undergo elective surgery under general anesthesia, ages between 18-80, BMI ≥ 30 kg/m2, ASA I-II were included in the study. During the preoperative evaluation, patients' gender, age, height, weight, type of surgery, BMI, neck circumference, thyromental distance (TMM), sternomental distance (SMM), hyomental distance (HMM), neck extension, mouth opening and distance between incisors were measured and tooth structure was evaluated. OSAS was evaluated based on the ASA physical condition score and AHI. Mallampati Classification was recorded. Upper lip bite test was performed. Ultrasonographic measurements were made with the patient in the supine position and the head and neck in a neutral position. The Han Scale was used to evaluate difficult mask ventilation. The laryngoscopy image was evaluated and recorded with the Cormack-Lehane Classification, and ≥2b was accepted as difficult laryngoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy laryngoscopy | – | Other: UltrasoundCormack Lehane Classification 1-2a |
| Difficult laryngoscopy | – | Other: UltrasoundCormack Lehane Classification 2b-3-4 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- obese elective surgery patients
Key inclusion criteria (1 listed)
- Elective surgery, ages between 18-80 BMI over 30, ASA I-II
Key exclusion criteria (1 listed)
- Facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history.
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 |
|---|---|---|
| UltrasoundMeasurement of the airway by ultrasound in obese patients. | Other | Difficult laryngoscopy, Easy laryngoscopy |
Primary outcome
Difficult laryngoscopy
Time frame: preoperative evaluation
To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.
1 secondary outcome
Difficult mask ventilation
Time frame: preoperative evaluation
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 23 Jun 2023.
- Derived from this study: PubMed 38997064Tasdemir O, Kocaoglu N, Demir HF, Ugun F, Sagir O. Ultrasound-based airway assessment in obese patients as a valuable tool for predicting difficult airway: an observational study. Braz J Anesthesiol. 2024 Nov-Dec;74(6):844539. doi: 10.1016/j.bjane.2024.844539. Epub 2024 Jul 10.
- Ultrasound As A New Tool In The Assessment Of Airway Difficulties: An Observational Study.Link provided by the sponsor.
- Development of a scoring system for predicting difficult intubation using ultrasonographyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Nazan Kocaoglu principal investigator
Balikesir University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Balikesir 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 1 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: finished, as of the sponsor's last update on 23 Jun 2023. 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?
Difficult laryngoscopy (time frame: preoperative evaluation). 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 NCT05896098, 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 23 Jun 2023.