Examining the Effects of Anthropometric Measurements on Difficult Airway Prediction

NCT07077317 | Completed

• 1 other identifier: E-41997688-050.99-177377
• Study Type: observational
• Target: 1,044
• Locations: 1 country
• Sites: 1

Brief Summary

Airway-related complications are among the leading causes of anesthesia-associated morbidity and mortality. Therefore, the ability to predict difficult mask ventilation, laryngoscopy, and intubation before induction is essential to ensure proper preparation in patients at risk and avoid unnecessary airway manipulations in low-risk individuals. While numerous studies have focused on predicting difficult intubation, most have limited sample sizes and do not consider postoperative critical respiratory events. In this prospective observational clinical study, we aim to investigate the relationship between commonly used preoperative airway assessment tools-including anthropometric measurements, Mallampati score, and the STOP-Bang questionnaire for obstructive sleep apnea-and the incidence of difficult mask ventilation, difficult laryngoscopy (Cormack-Lehane grading), difficult intubation, and critical respiratory events in the postoperative period. The study will include adult patients (≥18 years) classified as ASA I-IV undergoing surgery under general anesthesia with endotracheal intubation. Data will be collected preoperatively, intraoperatively, and in the post-anesthesia care unit (PACU) by experienced anesthesia personnel. Postoperative critical respiratory events are defined as unexpected hypoxemia, hypoventilation, reintubation, or interventions required for upper/lower airway obstruction.

Conditions

Difficult Airway; Difficult Airway Intubation; Airway Management

Keywords

mask ventilation; intubation; Cormack-Lehane; Airway Assessment

Outcome Measures

Primary Outcomes (4)

• Incidence of Difficult Mask Ventilation

  Evaluation of mask ventilation using a standard difficulty grading scale. 1. Mask Ventilation Successful 2. Mask Ventilation Requires Oral Airway 3. Mask Ventilation Requires Oral Airway And Assistant (Two Hands) 4. Mask Ventilation Failure

  Intraoperative (during anesthesia induction)

• Incidence of Difficult Laryngoscopy

  Cormack-Lehane grade III-IV views considered difficult laryngoscopy.

  Intraoperative (during laryngoscopy)

• Incidence of Difficult Intubation

  Defined as more than two attempts, or the requirement of adjuncts such as bougie, videolaryngoscope, or fiberoptic bronchoscope.

  Intraoperative (during intubation)

• Occurrence of Postoperative Critical Respiratory Events

  Events include unexpected hypoxemia (SpO₂ \< 90%), hypoventilation (RR \< 8/min or PaCO₂ \> 50 mmHg), reintubation, and active interventions for airway obstruction.

  Within the first 2 hours postoperatively (in PACU)

Secondary Outcomes (3)

• Correlation Between STOP-Bang Score and Difficult Airway Incidence

  Preoperative through intraoperative period

• Correlation Between Anthropometric Measurements and Critical Respiratory Events

  Preoperative to postoperative period

• Correlation Between Anthropometric Measurements and Difficult Airway Management

  Preoperative to intraoperative (induction period of anesthesia)

Interventions

Airway Assessment Using Standard Clinical Tools OTHER

Preoperative airway evaluation using routine physical measurements (e.g., Mallampati score, neck circumference, STOP-Bang questionnaire), and intraoperative/postoperative observation of airway-related parameters.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective surgical procedures requiring endotracheal intubation under general anesthesia at a tertiary hospital.

You may qualify if:

• Age ≥ 18 years,
• ASA Physical Status I, II, III or IV,
• Undergoing elective surgery under general anesthesia with endotracheal intubation,
• Written informed consent provided

You may not qualify if:

• History of head and neck surgery or trauma causing anatomical deformity,
• Known congenital or acquired airway abnormality,
• Cervical spine surgery or instability,
• Age \< 18 years

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Department of Anesthesiology, KUTAHYA CITY HOSPITAL

Kütahya, 43020, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: August 13, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 11, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)