NCT07316179

Brief Summary

This study is designed as a prospective observational study and will be conducted at the Health Sciences University Antalya Training and Research Hospital. Adult patients scheduled to undergo bariatric surgery will be included. The aim of this study is to compare the El Ganzouri Risk Index (EGRI) and airway ultrasonography (USG) parameters in predicting difficult intubation and to evaluate their relationship with the Cormack-Lehane (CL) score obtained during direct laryngoscopy. Before surgery, each participant will be evaluated using both the EGRI scoring system and airway USG. During general anesthesia, tracheal intubation will be performed using direct laryngoscopy, and data including the CL score, intubation time, number of attempts, and the need for videolaryngoscopy will be recorded based on the anesthesiologist's observations. The collected data will be analyzed by classifying participants according to the presence or absence of difficult intubation, and statistical comparisons will be performed between EGRI scores and airway ultrasonography parameters. The results of this study may contribute to improved preoperative airway assessment and enhanced patient safety in bariatric surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Dec 2025

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 Progress62%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

November 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

November 20, 2025

Last Update Submit

March 6, 2026

Conditions

Keywords

El Ganzouri Risk IndexDifficult airwayObesityAirway UltrasonographyAirway Management

Outcome Measures

Primary Outcomes (1)

  • Association between each individual ultrasound parameter and difficult laryngoscopy

    Difficult laryngoscopy will be defined as CL grades III-IV, which will serve as the reference standard. Each predefined airway ultrasonography parameter will be analyzed independently to evaluate its association with difficult laryngoscopy. No composite score will be calculated. The following preoperative airway ultrasonography measurements will be assessed individually: Tongue base thickness Hyomental distance in the neutral position Hyomental distance in the extended position Hyomental ratio (extension/neutral) Skin-to-hyoid distance Skin-to-epiglottis distance Skin-to-vocal cords (anterior commissure) distance Skin-to-cricoid cartilage distance Pre-epiglottic space depth Unit of Measure Centimeters (cm) for all linear measurements

    Baseline (preoperative period)

Secondary Outcomes (5)

  • Comparison of Diagnostic Performance Between the EGRI and Airway USG Measurements

    Baseline (preoperative period)

  • Association Between Airway Ultrasonography Parameters and Intubation Performance

    Perioperative period (during tracheal intubation)

  • Predictive Performance of the EGRI for Difficult Laryngoscopy

    Baseline (preoperative period)

  • Association Between Early Intraoperative Hemodynamic Instability and Difficult Laryngoscopy

    Perioperative period (first 30 minutes of surgery)

  • Incidence and Clinical Correlates of Difficult Laryngoscopy in Obese Adults Undergoing Bariatric Surgery

    Perioperative period (during tracheal intubation)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult participants aged 18 to 65 years with ASA physical status II or III who are scheduled to undergo elective bariatric surgery under general anesthesia. Eligible participants must provide written informed consent prior to inclusion in the study. Participants with upper airway anatomical pathology, previous tracheal or thyroid surgery, head or neck masses, history of radiotherapy to the head and neck region, cervical spine anomalies, or those unwilling to participate will be excluded.

You may qualify if:

  • Adult patients aged 18 to 65 years.
  • ASA physical status classification II or III.
  • Scheduled to undergo elective bariatric surgery under general anesthesia.
  • Patients who voluntarily agree to participate in the study and sign the informed consent form.

You may not qualify if:

  • Patients younger than 18 years or older than 65 years
  • Presence of upper airway anatomical pathology
  • History of tracheal or thyroid surgery.
  • History of radiotherapy to the head and neck region.
  • Cervical spine anomalies.
  • Individuals unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Antalya, 07050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehmet Tercan

    University of Health Sciences Antalya Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Ece Ilayda Tekdemir

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

January 5, 2026

Study Start

December 25, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 28, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations