Positive-Pressure vs Suction Extubation in Cesarean Patients (PPET)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxia; Anesthesia, General; Extubation; Atelectasis; Postoperative Respiratory Complication
• Intervention / Treatment: Procedure: Positive Pressure Extubation Technique (PPET); Procedure: Negative Pressure Extubation Technique (NPET)

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bagcılar
    • Istanbul, Bagcılar, Turkey (Türkiye)
      • Istanbul Medipol Mega University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult female patients aged 18 to 45 years.
• Scheduled for elective cesarean delivery under general anesthesia.
• Ability to provide written informed consent

Exclusion Criteria:

• Exclusion criteria included patients participating in another study,
• Patients refusing to participate,
• Uncooperative patients,
• Patients undergoing emergency surgery,
• American Society of Anesthesiologists (ASA) Physical Status Classification > 3,
• Patients with chronic respiratory failure, obstructive sleep apnea, and patients with anticipated difficult airways.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive-Pressure Extubation (PPET); Extubation was performed under continuous positive airway pressure (PEEP 6 cmH₂O, PS 12 cmH₂O) 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)
Active Comparator: Negative-Pressure Extubation (NPET); Extubation was performed under continuous suction during cuff deflation, representing the conventional technique.	Procedure: Negative Pressure Extubation Technique (NPET); Extubation performed under continuous suction during cuff deflation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative desaturation (SpO₂ < 92%)	The proportion of participants who experience oxygen desaturation, defined as peripheral oxygen saturation (SpO₂) below 92%, at any time point within the first 60 minutes after extubation.	Within the first 60 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peripheral Oxygen Saturation (SpO₂)	SpO₂ values measured at predefined intervals (1, 3, 5, 10, 15, 30, and 60 minutes) after extubation.	0-60 minutes post-extubation
Change in Heart Rate	Heart rate measurements recorded at predefined intervals after extubation.	0-60 minutes post-extubation
Change in Systolic and Diastolic Blood Pressure	Systolic and diastolic blood pressure were recorded at predefined intervals after extubation.	0-60 minutes post-extubation

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: NURDAN YILMAZ, Istanbul Medipol Mega University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Estimated): November 26, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypoxia; Anesthesia; Cesarean Section; Extubation; Postoperative Respiratory Complication; Positive pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Pulmonary Atelectasis
• Other Study ID Numbers: PPETRCT2024; Medipol University Ethics (Other Identifier: Ethics Approval No: 2025/1065(Medipol University))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to patient confidentiality and institutional policy. Summary data will be available upon reasonable request from the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No