- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06457165
The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-60 years
- ASA 1-3
- BMI ≥30 kg/m2
- ASA 1-3
- Scheduled for elective abdominal surgery under general anesthesia
Exclusion Criteria:
- <18 and >60 years
- ASA>3
- BMI<30
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
Noted for each patient.
Other Names:
Noted for each patient.
Other Names:
|
|
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. |
Noted for each patient.
Other Names:
Noted for each patient.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suprasternal Adipose Tissue Thickness
Time Frame: within 10 minutes before going into surgery
|
It is predicted that it may indicate difficult intubation.
|
within 10 minutes before going into surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abdominal circumference
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
|
Waist circumference
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
|
Arm circumference
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
|
Distance between incisions
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
|
Thyromental distance measurement
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
|
Sternomental distance measurement
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
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)
|
Noted for each patient.
|
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)
|
Noted for each patient.
|
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)
|
Noted for each patient.
|
1. minute after intubation(class 1-4; 1 means good and 4 means bad)
|
|
Age
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
|
Sex
Time Frame: within 10 minutes before going into surgery
|
Noted for each patient.
|
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)
|
Noted for each patient.
|
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
|
Noted for each patient.
|
within 10 minutes before going into surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayça Tuba Dumanlı Özcan, Ankara Bilkent City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Difficult Intubation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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