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Completed

NCT Number: NCT06457165

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Difficult Intubation

Device

Noted for each patient.

Other names: Age, ASA, BMI, Arm circumference, TMD, SMD, Distance between incisions, Abdominal circumference, Waist circumference, Suprasternal adipose tissue thickness, Mallampati, Cormack-Lehane score, Wilson score

Not Difficult Intubation

Device

Noted for each patient.

Other names: Age, ASA, BMI, Arm circumference, TMD, SMD, Distance between incisions, Abdominal circumference, Waist circumference, Suprasternal adipose tissue thickness, Mallampati, Cormack-Lehane score, Wilson score

Primary outcomes

  1. Suprasternal Adipose Tissue Thickness

    Time frame: within 10 minutes before going into surgery

    It is predicted that it may indicate difficult intubation.

Secondary outcomes

  1. Abdominal circumference

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  2. Waist circumference

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  3. Arm circumference

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  4. Distance between incisions

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  5. Thyromental distance measurement

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  6. Sternomental distance measurement

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  7. 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.

  8. Wilson score

    Time frame: within 10 minutes before going into surgery(grade 0-10; 0 means good, 10 means bad)

    Noted for each patient.

  9. Cormack-Lehane score

    Time frame: 1. minute after intubation(class 1-4; 1 means good and 4 means bad)

    Noted for each patient.

  10. Age

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  11. Sex

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

  12. ASA

    Time frame: within 10 minutes before going into surgery(grades 1-6; 1 means good and 6 means bad)

    Noted for each patient.

  13. BMI

    Time frame: within 10 minutes before going into surgery

    Noted for each patient.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Predicting Difficult Intubation in Obese Patients: The Role of Anthropometric Measurements and Ultrasonograpic Suprasternal Adipose Tissue Thickness

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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