Prediction of Difficult Airway in Cesarean Section Using Preoperative Airway Assessment Tests

NCT07340346 | Completed

• 1 other identifier: Difficult Airway in Cesarean
• Study Type: observational
• Target: 546
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study (OB-DIFF-AIRWAY: Obstetric Difficult Airway Study) aimed to evaluate the accuracy of commonly used preoperative airway assessment tests in predicting difficult airway management in obstetric patients undergoing cesarean section. Difficult airway remained a significant cause of anesthesia-related complications, particularly in pregnant patients due to physiological and anatomical changes. Adult pregnant women scheduled for elective or urgent cesarean section underwent standard preoperative airway assessment, including Mallampati classification, thyromental distance, interincisor distance, neck circumference, and other routine clinical evaluations. Airway management during anesthesia was performed according to standard clinical practice. No additional intervention was applied for the purpose of the study. The relationship between preoperative airway assessment findings and actual airway management difficulty was analyzed. The results of this study may help improve preoperative airway evaluation strategies and enhance patient safety in obstetric anesthesia.

Conditions

Difficult Airway; Airway Management; Obstetric Anesthesia

Keywords

Preoperative Airway Assessment; Mallampati Score; Difficult Intubation; Obstetric Patients

Outcome Measures

Primary Outcomes (1)

• Prediction of Difficult Airway Using Preoperative Airway Assessment Tests

  The primary outcome is the ability of preoperative airway assessment tests to predict difficult airway management during cesarean delivery. Predictive performance was evaluated using sensitivity, specificity, positive and negative predictive values, and the area under the receiver operating characteristic (ROC) curve (AUC). Difficult airway was defined based on predefined intraoperative criteria such as difficulty in mask ventilation, difficult laryngoscopy, or difficult tracheal intubation as assessed by the attending anesthesiologist.

  During anesthesia induction

Secondary Outcomes (2)

• Incidence of Difficult Airway in Obstetric Patients

  During anesthesia induction

• Association Between Individual Airway Assessment Tests and Difficult Airway

  During anesthesia induction

Study Arms (1)

Obstetric Patients Undergoing Cesarean Section

Adult obstetric patients undergoing elective or urgent cesarean section who received standard preoperative airway assessment as part of routine anesthetic care. Airway management was performed according to institutional clinical practice without any study-related intervention.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study. No experimental intervention was assigned. All assessments and airway management procedures were performed as part of routine clinical practice.

Obstetric Patients Undergoing Cesarean Section

Eligibility Criteria

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

Study Population

Adult pregnant women aged 18 years and older who underwent elective or urgent cesarean section at a tertiary university hospital. All participants received standard preoperative airway assessment as part of routine anesthetic care.

You may qualify if:

• Adult obstetric patients aged 18 years or older
• Scheduled for elective or urgent cesarean section
• Undergoing routine preoperative airway assessment
• Provided written informed consent

You may not qualify if:

• Known congenital or acquired airway pathology
• History of difficult airway requiring advanced airway techniques
• Emergency situations requiring immediate airway management without standard preoperative assessment
• Incomplete or missing airway assessment data

Sponsors & Collaborators

• Akdeniz University Hospital: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Türkiye, 07000, Turkey (Türkiye)

Location

Related Publications (3)

• Mushambi MC, Jaladi S. Airway management and training in obstetric anaesthesia. Curr Opin Anaesthesiol. 2016 Jun;29(3):261-7. doi: 10.1097/ACO.0000000000000309.

  PMID: 26844863 BACKGROUND

• Freedman RL, Lucas DN. MBRRACE-UK: saving lives, improving mothers' care - implications for anaesthetists. Int J Obstet Anesth. 2015 May;24(2):161-73. doi: 10.1016/j.ijoa.2015.03.004. Epub 2015 Mar 14.

  PMID: 25841640 BACKGROUND

• McKeen DM, George RB, O'Connell CM, Allen VM, Yazer M, Wilson M, Phu TC. Difficult and failed intubation: Incident rates and maternal, obstetrical, and anesthetic predictors. Can J Anaesth. 2011 Jun;58(6):514-24. doi: 10.1007/s12630-011-9491-9. Epub 2011 Apr 7.

  PMID: 21472485 BACKGROUND

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• ALİ DEMİRTAŞ

  Akdeniz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Member, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: August 23, 2023
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)