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Clinical Trials/NCT07340346
NCT07340346
Completed
Not Applicable

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

Akdeniz University Hospital1 site in 1 country546 target enrollmentStarted: August 23, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Akdeniz University Hospital
Enrollment
546
Locations
1
Primary Endpoint
Prediction of Difficult Airway Using Preoperative Airway Assessment Tests

Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: No intervention (observational study) (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Incidence of Difficult Airway in Obstetric Patients(During anesthesia induction)
  • Association Between Individual Airway Assessment Tests and Difficult Airway(During anesthesia induction)

Investigators

Sponsor
Akdeniz University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ALİ DEMİRTAŞ

Faculty Member, Department of Anesthesiology and Reanimation

Akdeniz University Hospital

Study Sites (1)

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