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

Completed

• Conditions: Obesity; OSA
• Interventions: Diagnostic Test: STOP-Bang score >= 3 with factors predicting difficult intubation

• Registration Number: NCT06265064
• Lead Sponsor: Khon Kaen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-11
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Study First Submitted: 2023-12-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-difficult mask ventilation	STOP-Bang score >= 3 with factors predicting difficult 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 non-difficult mask ventilation
Difficult mask ventilation	STOP-Bang score >= 3 with factors predicting difficult 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

Primary Outcome Measures

Name	Time	Method
Difficult mask ventilation	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 Outcome Measures

Name	Time	Method
Resipiratory complication	during mask ventilation until the completion of intubation.	1. Airway trauma; 2. Desaturation Spo2\<90% in 2 minutes; 3. Regurgitation; 4. Aspiration

Trial Locations

Locations (1)

KhonKaen University; 🇹🇭 Nai Muang, Khonkaen, Thailand