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Difficult Airway Prediction by Integrating STOP-BANG Criteria

Enhancing Difficult Airway Prediction in Obese Patients: Integrating STOP-BANG With Additional Airway Assessment Tools

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07493356
Enrollment
233
Registered
2026-03-25
Start date
2026-03-09
Completion date
2026-09-08
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult or Failed, Ventilatory Defect

Keywords

Laryngoscopy, Ventilation of lungs, Bag-mask, General Anesthesia

Brief summary

This study is being done to determine the diagnostic accuracy of the STOP-BANG questionnaire in predicting difficult mask ventilation and intubation among obese patients. During the preoperative assessment, eligible participants will be enrolled in the study. The modified Mallampati score, thyromental distance, mouth opening, and upper lip bite tests will be performed along with STOP-Bang scores. Later in the operating room, general anesthesia will be given, and bag-mask ventilation and intubation grade will be assessed and recorded. A correlation will be assessed between the difficult airway assessment findings, along with the STOP-BANG score and the bas-mask difficulty scores and intubation grades.

Detailed description

After approval of the Ethical Review Committee (ERC), the study will commence. Participants will be selected from the scheduled elective surgical lists of all surgical departments. Written informed consent will be acquired from all study participants. The resident will document demographic variables (age, height, weight, and gender) and STOP-Bang scores during the pre-anesthesia assessment for eligible participants. A STOP-Bang score of ≥ 3 will suggest a higher risk for difficult airway, whereas a score of \< 3 will suggest a lower risk. Anesthesia residents under the supervision of a consultant anesthesiologist will record intraoperative observations on a study form. A qualified anesthesia provider performing bag-mask ventilation must have at least three years of anesthesia experience. The primary investigator will gather the questionnaire and intraoperative data form from the trained anesthesiologist. The anesthesiologist managing the airway will be unaware of the STOP-Bang score. Standard monitoring (ECG, non-invasive blood pressure, and peripheral oxygen saturation) will be attached, and baseline readings will be recorded. Pre-oxygenation will be performed for three minutes. Anesthesia will be induced with nalbuphine 100 micrograms/kg and propofol 2 mg/kg until the patient becomes unresponsive to verbal communication; atracurium 0.6 mg/kg will be given after assessing ventilation. Mask ventilation will be carried out for three minutes with the patient's head in the sniffing position. The supervising consultant will decide when to intervene if the primary anesthetist is unable to mask ventilate the patient. Following three minutes of mask ventilation, the trachea will be intubated using a Macintosh laryngoscope. The endotracheal tube's correct position will be confirmed by monitoring a persistent end-tidal CO₂ waveform, visible chest rise, and bilateral chest auscultation.

Interventions

None listed

Sponsors

Sindh Institute of Urology and Transplantation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

Inclusion criteria

* Male \& Female aged 18-60 years. * Body mass index 30 or more * American Society of Anesthesiologists (ASA) status II-III. * Scheduled for elective surgery under general anesthesia with endotracheal intubation.

Exclusion criteria

* Patients' refusal to participate. * American Society of Anesthesiologists (ASA) IV \& V. * Neuromuscular diseases or facial abnormalities. * Cardiothoracic, head and neck, or emergency surgery. * Previously diagnosed with OSA (by polysomnography) will be excluded. * Any airway-related anatomical deformity (e.g., Down's syndrome). * History of radiation exposure. * Patient with mouth opening \<2 fingers

Design outcomes

Primary

MeasureTime frameDescription
Adequate Bag-Mask VentilationOnly once, after giving general anesthesia but before an endotracheal tube is put in the tracheaWhen an anesthetized patient is being manually ventilated by an anesthesia bag and a face mask and achieving a tidal volume of 5 ml/kg, it will be called adequate mask ventilation. * Easy if a single anesthesiologist achieves visible adequate chest rise and an end-tidal CO₂ graph. * Moderately difficult, if there is a slight chest rise, a low end-tidal CO₂ graph, but peripheral oxygen saturation is maintained above 97%. * Difficult if there is no visible chest rise, minimal or no end-tidal CO₂ graph, or if peripheral oxygen saturation drops to less than 95% but becomes normal with use of an oral airway (Guedel airway) or a laryngeal mask airway (LMA), or if two anesthesia providers are required for adequate mask ventilation. * Very difficult if peripheral oxygen saturation drops to 90% or less despite the use of airway adjuncts (Guedel airway or LMA).
Difficult Tracheal IntubationOnly once, after giving general anesthesia and 3-minute bag-mask ventilation for adequate muscle relaxation effect, then direct laryngoscopy will be performed to put the endotracheal tube in the tracheaDifficult tracheal intubation will be defined as, one that requires external laryngeal manipulation, laryngoscopy requiring more than 3 attempts at intubation, intubation requiring nonstandard equipment or approaches, or the inability to intubate at all

Countries

Pakistan

Contacts

CONTACTSyed M Abbas, FCPS
smabbas69@hotmail.com02199215718
PRINCIPAL_INVESTIGATORSyed M Abbas, FCPS

Sindh Institute of Urology and Transplantation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026