Prediction of Difficult Airway in Cesarean Section Using Preoperative Airway Assessment Tests (OB-DIFF-AIRWAY)

January 6, 2026 updated by: ALİ DEMİRTAŞ, Akdeniz University Hospital

Evaluation of the Reliability of Preoperative Airway Assessment Tests in Predicting Difficult Airway Management in Obstetric Patients Undergoing Cesarean Section

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.

Study Overview

Detailed Description

Difficult airway management is one of the most critical challenges in anesthetic practice and is associated with increased morbidity and mortality. Obstetric patients represent a particularly high-risk population due to pregnancy-related physiological changes such as airway edema, weight gain, reduced functional residual capacity, and increased oxygen consumption. Despite routine use of various preoperative airway assessment tests, their predictive value in obstetric patients remains controversial.

This prospective observational study was conducted to evaluate the reliability of commonly used preoperative airway assessment tests in predicting difficult airway management in patients undergoing cesarean section. The study was performed at Akdeniz University Hospital between August 23, 2023, and August 23, 2024.

Adult obstetric patients scheduled for elective or urgent cesarean section under anesthesia were included. Patients with known airway pathology, prior difficult airway history requiring advanced airway techniques, or incomplete airway assessment data were excluded according to predefined criteria.

Preoperative airway assessment was performed as part of routine anesthetic evaluation and included Mallampati classification, thyromental distance, interincisor distance, neck circumference, and other standard clinical parameters. No additional procedures or interventions were introduced for research purposes. Anesthetic management and airway techniques were determined by the attending anesthesiologist in accordance with institutional standards.

Airway management difficulty was recorded intraoperatively based on predefined clinical criteria, including difficulty with mask ventilation, laryngoscopy, or tracheal intubation. The association between preoperative airway assessment findings and observed airway difficulty was analyzed using appropriate statistical methods. Difficult airway management was defined as the presence of at least one of the following predefined intraoperative criteria:

difficult mask ventilation (Han classification ≥ 3), difficult laryngoscopy (Cormack-Lehane grade III-IV), or failure of tracheal intubation on the first attempt.

Patients were enrolled using a consecutive non-probability sampling approach, including all eligible obstetric patients undergoing cesarean delivery during the study period.

The sample size was determined by the consecutive inclusion of all eligible patients undergoing cesarean delivery at the study center during the predefined study period.

The primary objective of the study was to assess the predictive value of individual and combined airway assessment tests for difficult airway management in obstetric patients. Secondary objectives included identifying potential risk factors associated with airway difficulty and evaluating the overall incidence of difficult airway in the study population.

The findings of this study are expected to contribute to improved preoperative airway evaluation and risk stratification in obstetric anesthesia, thereby enhancing patient safety and clinical outcomes.

Study Type

Observational

Enrollment (Actual)

546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Türkiye
      • Antalya, Türkiye, Turkey (Türkiye), 07000
        • Akdeniz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of Difficult Airway Using Preoperative Airway Assessment Tests
Time Frame: During anesthesia induction

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Difficult Airway in Obstetric Patients
Time Frame: During anesthesia induction
The incidence of difficult airway management among obstetric patients undergoing cesarean section was evaluated based on predefined clinical criteria.
During anesthesia induction
Association Between Individual Airway Assessment Tests and Difficult Airway
Time Frame: During anesthesia induction
The association between individual preoperative airway assessment tests and the occurrence of difficult airway management was analyzed to identify potential risk factors.
During anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ALİ DEMİRTAŞ, Akdeniz University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Actual)

August 23, 2024

Study Completion (Actual)

August 23, 2024

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Difficult Airway in Cesarean

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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