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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06265064
• Other study ID #: KhonKaenUniversity
• Status: Completed
• Start date: July 11, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• OSA

Intervention

Diagnostic Test:
• STOP-Bang score >= 3 with factors predicting difficult intubation
patients with STOP-Bang score >= 3 with Mallampati score = 3 or neck circumference >42 cm or mentothyroid distance <6 cm

Locations

Country	Name	City	State
Thailand	KhonKaen University	Nai Muang	Khonkaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficult mask ventilation	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	After the induction of general anesthesia, observe the assisted mask ventilation. End the collection of the primary outcome before endotracheal tube intubation.
Secondary	Resipiratory complication	Airway trauma; Desaturation Spo2<90% in 2 minutes; Regurgitation; Aspiration	during mask ventilation until the completion of intubation.