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

NCT ID: NCT07340346

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

546 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-23

Study Completion Date

2024-08-23

Brief Summary

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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

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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.

Conditions

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Difficult Airway Airway Management Obstetric Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention (observational study)

Intervention Type 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.

Interventions

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No intervention (observational study)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University Hospital

OTHER

Sponsor Role lead

Responsible Party

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ALİ DEMİRTAŞ

Faculty Member, Department of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALİ DEMİRTAŞ

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Hospital

Locations

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Akdeniz University Hospital

Antalya, Türkiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26844863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25841640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21472485 (View on PubMed)

Other Identifiers

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Difficult Airway in Cesarean

Identifier Type: -

Identifier Source: org_study_id

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