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

Can Combination of STOP-Bang Score and Factors Predicting Difficult Intubation Improve Accuracy of Prediction 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

Study Overview

• Status: Completed
• Conditions: Obesity; OSA
• Intervention / Treatment: Diagnostic test: STOP-Bang score >= 3 with factors predicting difficult intubation

• Study Type: Observational
• Enrollment (Actual): 278

Contacts and Locations

Study Locations

• Thailand
  • Khonkaen
    • Nai Muang, Khonkaen, Thailand, +66
      • KhonKaen university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Calculation by Diagnotic test that used sensitivity and Specificity of the precedent journal "Accuracy of STOP-Bang Questionnaire in Predicting Difficult Mask Ventilation: An Observational Study by Marium N. Khan , Aliya Ahmed" total population 278 patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
non-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 non-difficult mask ventilation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resipiratory complication	Airway trauma; Desaturation Spo2<90% in 2 minutes; Regurgitation; Aspiration	during mask ventilation until the completion of intubation.

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; mask ventilation
• Other Study ID Numbers: KhonKaenUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No