The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness

June 13, 2024 updated by: Ayça Özcan, Ankara City Hospital Bilkent

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

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

Observational

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • ASA
  • BMI
  • Age
  • Arm circumference
  • TMD
  • SMD
  • Distance between incisions
  • Abdominal circumference
  • Waist circumference
  • Suprasternal adipose tissue thickness
  • Mallampati
  • Cormack-Lehane score
  • Wilson score
Noted for each patient.
Other Names:
  • ASA
  • BMI
  • Age
  • Arm circumference
  • TMD
  • SMD
  • Distance between incisions
  • Abdominal circumference
  • Waist circumference
  • Suprasternal adipose tissue thickness
  • Mallampati
  • Cormack-Lehane score
  • Wilson score
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:
  • ASA
  • BMI
  • Age
  • Arm circumference
  • TMD
  • SMD
  • Distance between incisions
  • Abdominal circumference
  • Waist circumference
  • Suprasternal adipose tissue thickness
  • Mallampati
  • Cormack-Lehane score
  • Wilson score
Noted for each patient.
Other Names:
  • ASA
  • BMI
  • Age
  • Arm circumference
  • TMD
  • SMD
  • Distance between incisions
  • Abdominal circumference
  • Waist circumference
  • Suprasternal adipose tissue thickness
  • Mallampati
  • Cormack-Lehane score
  • Wilson score

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayça Tuba Dumanlı Özcan, Ankara Bilkent City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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