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NCT Number: NCT06265064

STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients

The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.

The main question[s] it aims to answer are:

* Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients? * Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.

Participants who undergoing to elective surgery under general anesthesia will

* Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation) * In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.

If there is a comparison group:

Researchers will compare obese patients with/without high STOP bang score >=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference > 42 cm, Thyromental distance < 6 cm)to prediction difficult mask ventilation

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases OSA Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KhonKaen University

Nai Muang, Khonkaen, +66, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI ≥ 25 kg/m2
  • Age > 18 years old
  • undergoing elective surgery under general anesthesia with endotracheal intubation

Exclusion criteria

  • History of difficult mask and intubation
  • Maxillofacial or upper airway malformation
  • History of C-spine disease such as trauma, degeneration
  • Pregnancy
  • Rapid sequence induction technique

Treatment and study plan

STOP-Bang score >= 3 with factors predicting difficult intubation

Diagnostic Test

patients with STOP-Bang score >= 3 with Mallampati score ≥ 3 or neck circumference >42 cm or mentothyroid distance <6 cm

Primary outcomes

  1. Difficult mask ventilation

    Time frame: After the induction of general anesthesia, observe the assisted mask ventilation. End the collection of the primary outcome before endotracheal tube intubation.

    Difficult Mask Ventilation Grading (by Han et al.) Grade 1 mask ventilation can be easily performed by a single person Grade 2 requires the use of equipment such as an oropharyngeal airway Grade 3 necessitates the involvement of two or more personnel for mask ventilation or increasing oxygen flow Grade 4 indicates an inability to perform mask ventilation If the grade is ≥ 3, it signifies difficult mask ventilation

Secondary outcomes

  1. Resipiratory complication

    Time frame: during mask ventilation until the completion of intubation.

    • Airway trauma
    • Desaturation Spo2<90% in 2 minutes
    • Regurgitation
    • Aspiration

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Can Combination of STOP-Bang Score and Factors Predicting Difficult Intubation Improve Accuracy of Prediction Difficult Mask Ventilation in Obese Patients?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Feb 20, 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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