Intubation; Difficult or FailedNCT06457165
The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness
An observational study of Intubation; Difficult or Failed and Obesity, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation; Difficult or Failed, Obesity, Anesthesia
- What is being tested?
- Difficult Intubation and Not Difficult Intubation
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 40 patients between the ages of 18-60 years, ASA 1-3, BMI ≥30 kg/m2, ASA 1-3, scheduled for elective abdominal surgery under general anesthesia.
Who may be able to join
- 18-60 years
- ASA 1-3
- BMI ≥30 kg/m2
- ASA 1-3
- Scheduled for elective abdominal surgery under general anesthesia
Who cannot join
- <18 and >60 years
- ASA>3
- BMI<30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Difficult Intubation in Obese Patients: The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness
Prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications.
In this study, the investigators aimed to evaluate whether anthropometric measurements are superior in defining difficult preoperative airways.
Read the detailed description
The World Health Organization (WHO) defines obesity, the incidence of which has increased significantly worldwide and is one of the important causes of difficult airway in terms of anesthesia, as obesity when the body mass index (BMI) is above 30. Access to the upper airway is difficult in obese patients, in whom excessive adipose tissue accumulates in the breast, neck, chest, and abdomen. Determining preoperative difficult intubation parameters in obese patients and entering the case preparation both reduce the risk of repeated intubation and prevent intraoperative and postoperative complications.
However, there are still insufficient tests to predict difficult intubation. Many studies have shown that multiple factors such as Mallampati score, high body mass index (BMI), increased neck circumference, and the ratio of neck circumference to thyromental distance are predictors of difficult intubation in obese patients. The introduction of ultrasonography into daily use has led to the use of ultrasonographic parameters in predicting difficult intubation and laryngoscopy. In this study, the investigators aimed to evaluate whether ultrasonography is useful in defining difficult preoperative airways, in addition to anthropometric measurements.
- Conditions
- Intubation; Difficult or Failed, Obesity, Anesthesia
- Being tested
- Difficult Intubation, Not Difficult Intubation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficult IntubationDevice
Also called Age, ASA, BMI, Arm circumference
Noted for each patient.
Not Difficult IntubationDevice
Also called Age, ASA, BMI, Arm circumference
Noted for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Difficult Intubation | Abdominal circumference, waist circumference, arm circumference, distance between incisions,TMD and SMD measurements, Mallampati test, Wilson score, and suprasternal subcutaneous adipose tissue thickness were measured and recorded. ECG, SBP and DBP, and SpO2 monitoring were performed. Pre-oxygenation was performed using a 100% oxygen face mask for 3 min before the induction of anesthesia. Induction of anesthesia was achieved with IV 1 mg/kg lidocaine, 0.125 mcgr/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. After 2 min of adequate muscle relaxation, the patient was intubated with an endotracheal tube of appropriate diameter. Cormack-Lehane score was evaluated during laryngoscopy. Patients with more than 3 intubation attempts by an experienced anesthesiologist were considered difficult to intubate. In maintenance, 0.1 mcg/kg/h remifentanil was administered in sevoflurane O2-air mixture.
Age, sex, body weight,BMI, and ASA scores were recorded. Receives: Device: Difficult Intubation; Device: Not Difficult Intubation | |
| Not Difficult Intubation | Abdominal circumference, waist circumference, arm circumference, distance between incisions,TMD and SMD measurements, Mallampati test, Wilson score, and suprasternal subcutaneous adipose tissue thickness were measured and recorded. ECG, SBP and DBP, and SpO2 monitoring were performed. Pre-oxygenation was performed using a 100% oxygen face mask for 3 min before the induction of anesthesia. Induction of anesthesia was achieved with IV 1 mg/kg lidocaine, 0.125 mcgr/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. After 2 min of adequate muscle relaxation, the patient was intubated with an endotracheal tube of appropriate diameter. Cormack-Lehane score was evaluated during laryngoscopy. Patients with more than 3 intubation attempts by an experienced anesthesiologist were considered difficult to intubate. In maintenance, 0.1 mcg/kg/h remifentanil was administered in sevoflurane O2-air mixture.
Age, sex, body weight,BMI, and ASA scores were recorded. Receives: Device: Difficult Intubation; Device: Not Difficult Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suprasternal Adipose Tissue Thickness
It is predicted that it may indicate difficult intubation.
Measured: within 10 minutes before going into surgery
Secondary outcomes (13)
Abdominal circumference
Noted for each patient.
Measured: within 10 minutes before going into surgery
Waist circumference
Noted for each patient.
Measured: within 10 minutes before going into surgery
Arm circumference
Noted for each patient.
Measured: within 10 minutes before going into surgery
Distance between incisions
Noted for each patient.
Measured: within 10 minutes before going into surgery
Thyromental distance measurement
Noted for each patient.
Measured: within 10 minutes before going into surgery
Sternomental distance measurement
Noted for each patient.
Measured: within 10 minutes before going into surgery
Mallampati Score
Noted for each patient.
Measured: within 10 minutes before going into surgery(class 1-4; 1 means good and 4 means bad)
Wilson score
Noted for each patient.
Measured: within 10 minutes before going into surgery(grade 0-10; 0 means good, 10 means bad)
Cormack-Lehane score
Noted for each patient.
Measured: 1. minute after intubation(class 1-4; 1 means good and 4 means bad)
Age
Noted for each patient.
Measured: within 10 minutes before going into surgery
Sex
Noted for each patient.
Measured: within 10 minutes before going into surgery
ASA
Noted for each patient.
Measured: within 10 minutes before going into surgery(grades 1-6; 1 means good and 6 means bad)
BMI
Noted for each patient.
Measured: within 10 minutes before going into surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2024
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.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Özcan, Ankara City Hospital Bilkent
- Investigators
- Ayça Tuba Dumanlı Özcan, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457165
- Sponsor's protocol ID
- Difficult Intubation
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Difficult Intubation in Obese Patients: The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness
- ClinicalTrials.gov ID
- NCT06457165
- Acronym / sponsor ID
- Difficult Intubation
- Conditions
- Intubation; Difficult or Failed, Obesity, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 13 Jun 2024 (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.
Prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications.
In this study, the investigators aimed to evaluate whether anthropometric measurements are superior in defining difficult preoperative airways.
Detailed description
The World Health Organization (WHO) defines obesity, the incidence of which has increased significantly worldwide and is one of the important causes of difficult airway in terms of anesthesia, as obesity when the body mass index (BMI) is above 30. Access to the upper airway is difficult in obese patients, in whom excessive adipose tissue accumulates in the breast, neck, chest, and abdomen. Determining preoperative difficult intubation parameters in obese patients and entering the case preparation both reduce the risk of repeated intubation and prevent intraoperative and postoperative complications.
However, there are still insufficient tests to predict difficult intubation. Many studies have shown that multiple factors such as Mallampati score, high body mass index (BMI), increased neck circumference, and the ratio of neck circumference to thyromental distance are predictors of difficult intubation in obese patients. The introduction of ultrasonography into daily use has led to the use of ultrasonographic parameters in predicting difficult intubation and laryngoscopy. In this study, the investigators aimed to evaluate whether ultrasonography is useful in defining difficult preoperative airways, in addition to anthropometric measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult Intubation | – | Device: Difficult Intubation, Device: Not Difficult IntubationAbdominal circumference, waist circumference, arm circumference, distance between incisions,TMD and SMD measurements, Mallampati test, Wilson score, and suprasternal subcutaneous adipose tissue thickness were measured and recorded. ECG, SBP and DBP, and SpO2 monitoring were performed. Pre-oxygenation was performed using a 100% oxygen face mask for 3 min before the induction of anesthesia. Induction of anesthesia was achieved with IV 1 mg/kg lidocaine, 0.125 mcgr/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. After 2 min of adequate muscle relaxation, the patient was intubated with an endotracheal tube of appropriate diameter. Cormack-Lehane score was evaluated during laryngoscopy. Patients with more than 3 intubation attempts by an experienced anesthesiologist were considered difficult to intubate. In maintenance, 0.1 mcg/kg/h remifentanil was administered in sevoflurane O2-air mixture. Age, sex, body weight,BMI, and ASA scores were recorded. |
| Not Difficult Intubation | – | Device: Difficult Intubation, Device: Not Difficult IntubationAbdominal circumference, waist circumference, arm circumference, distance between incisions,TMD and SMD measurements, Mallampati test, Wilson score, and suprasternal subcutaneous adipose tissue thickness were measured and recorded. ECG, SBP and DBP, and SpO2 monitoring were performed. Pre-oxygenation was performed using a 100% oxygen face mask for 3 min before the induction of anesthesia. Induction of anesthesia was achieved with IV 1 mg/kg lidocaine, 0.125 mcgr/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. After 2 min of adequate muscle relaxation, the patient was intubated with an endotracheal tube of appropriate diameter. Cormack-Lehane score was evaluated during laryngoscopy. Patients with more than 3 intubation attempts by an experienced anesthesiologist were considered difficult to intubate. In maintenance, 0.1 mcg/kg/h remifentanil was administered in sevoflurane O2-air mixture. Age, sex, body weight,BMI, and ASA scores were recorded. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 40 patients between the ages of 18-60 years, ASA 1-3, BMI ≥30 kg/m2, ASA 1-3, scheduled for elective abdominal surgery under general anesthesia.
Key inclusion criteria (5 listed)
- 18-60 years
- ASA 1-3
- BMI ≥30 kg/m2
- ASA 1-3
- Scheduled for elective abdominal surgery under general anesthesia
Key exclusion criteria (3 listed)
- <18 and >60 years
- ASA>3
- BMI<30
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 |
|---|---|---|
| Difficult IntubationAlso: Age, ASA, BMI, Arm circumferenceNoted for each patient. | Device | Difficult Intubation, Not Difficult Intubation |
| Not Difficult IntubationAlso: Age, ASA, BMI, Arm circumferenceNoted for each patient. | Device | Difficult Intubation, Not Difficult Intubation |
Primary outcome
Suprasternal Adipose Tissue Thickness
Time frame: within 10 minutes before going into surgery
It is predicted that it may indicate difficult intubation.
13 secondary outcomes
Abdominal circumference
Time frame: within 10 minutes before going into surgery
Waist circumference
Time frame: within 10 minutes before going into surgery
Arm circumference
Time frame: within 10 minutes before going into surgery
Distance between incisions
Time frame: within 10 minutes before going into surgery
Thyromental distance measurement
Time frame: within 10 minutes before going into surgery
Sternomental distance measurement
Time frame: within 10 minutes before going into surgery
Mallampati Score
Time frame: within 10 minutes before going into surgery(class 1-4; 1 means good and 4 means bad)
Wilson score
Time frame: within 10 minutes before going into surgery(grade 0-10; 0 means good, 10 means bad)
Cormack-Lehane score
Time frame: 1. minute after intubation(class 1-4; 1 means good and 4 means bad)
Age
Time frame: within 10 minutes before going into surgery
Sex
Time frame: within 10 minutes before going into surgery
ASA
Time frame: within 10 minutes before going into surgery(grades 1-6; 1 means good and 6 means bad)
BMI
Time frame: within 10 minutes before going into surgery
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 14 Jun 2024.
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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.
Ayça Tuba Dumanlı Özcan principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult or Failed and Obesity, run by Ankara City Hospital Bilkent 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 5 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 14 Jun 2024. 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?
Suprasternal Adipose Tissue Thickness (time frame: within 10 minutes before going into surgery). 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 14 Jun 2024.