NCT07493356

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 9, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

LaryngoscopyVentilation of lungsBag-maskGeneral Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Adequate Bag-Mask Ventilation

    When 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).

    Only once, after giving general anesthesia but before an endotracheal tube is put in the trachea

  • Difficult Tracheal Intubation

    Difficult 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

    Only 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 trachea

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

RECRUITING

Study Officials

  • Syed M Abbas, FCPS

    Sindh Institute of Urology and Transplantation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed M Abbas, FCPS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 8, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data will not be shared

Locations