NCT07251686

Positive-Pressure vs Suction Extubation in Cesarean Patients

Impact of Extubation Technique on Postoperative Pulmonary Outcomes: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Extubation represents a vulnerable phase of general anesthesia, during which airway secretions, reduced functional residual capacity, and diminished upper airway tone may contribute to hypoxemia and other respiratory complications. Pregnant women are particularly susceptible due to decreased lung volumes, increased oxygen consumption, and airway edema associated with pregnancy. The Positive-Pressure Extubation Technique (PPET) has been proposed as a strategy to reduce the migration of secretions toward the distal airways during cuff deflation, potentially improving lung aeration and gas exchange. Unlike conventional suction-based methods, PPET uses continuous positive pressure to maintain airflow direction, theoretically minimizing micro-aspiration and early atelectasis formation. Although PPET has demonstrated benefits in pediatric and mixed surgical populations, evidence regarding its application in obstetric anesthesia remains scarce. This study aims to evaluate whether positive-pressure extubation provides physiological advantages over conventional negative-pressure extubation in adult patients undergoing cesarean delivery under general anesthesia. By examining postoperative respiratory stability and hemodynamic responses, the study is expected to clarify the clinical importance of tailored extubation strategies in populations with reduced pulmonary reserve.

Conditions

• Postoperative Respiratory Complication
• Atelectasis
• Anesthesia, General
• Extubation
• Hypoxia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-11-10
• Completion: 2025-11-10
• First posted: 2025-11-26
• Last updated: 2025-12-04

Locations

1 site across 1 country: Turkey (Türkiye)