Positive-Pressure vs Suction Extubation in Cesarean Patients
NCT07251686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-12-04
Summary
This randomized controlled trial aims to evaluate the effects of two tracheal extubation techniques on postoperative oxygenation and early respiratory outcomes in adult women undergoing elective cesarean delivery under general anesthesia. A total of 120 participants will be randomly assigned to the Positive Pressure Extubation Technique (PPET) group or the Negative Pressure Extubation Technique (NPET) group.
In the PPET group, extubation will be performed while maintaining positive airway pressure during cuff deflation, whereas in the NPET group, extubation will be performed under continuous suction. The primary outcome will be the incidence of postoperative desaturation, defined as peripheral oxygen saturation (SpO₂) below 92% within the first 60 minutes after extubation.
Secondary outcomes will include serial measurements of oxygen saturation, heart rate, and blood pressure, along with exploratory analyses assessing the relationship between body mass index, comorbidities, and desaturation risk. The trial is intended to determine whether PPET provides physiological advantages over NPET during tracheal extubation in this surgical population.
Conditions
- Postoperative Respiratory Complication
- Atelectasis
- Anesthesia, General
- Extubation
- Hypoxia
Interventions
- PROCEDURE
-
Negative Pressure Extubation Technique (NPET)
Extubation performed under continuous suction during cuff deflation.
- PROCEDURE
-
Positive Pressure Extubation Technique (PPET)
Extubation performed under continuous positive airway pressure during cuff deflation (PEEP 6 cmH₂O, PS 12 cmH₂O)
Sponsors & Collaborators
-
Medipol University
lead OTHER
Principal Investigators
-
NURDAN YILMAZ · Istanbul Medipol Mega University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2025-11-10
- Completion
- 2025-11-10
Countries
- Turkey (Türkiye)
Study Locations
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