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Completed

NCT Number: NCT07251686

Positive-Pressure vs Suction Extubation in Cesarean Patients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol Mega University Hospital

Istanbul, Bagcılar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Negative Pressure Extubation Technique (NPET)

Procedure

Extubation performed under continuous suction during cuff deflation.

Positive Pressure Extubation Technique (PPET)

Procedure

Extubation performed under continuous positive airway pressure during cuff deflation (PEEP 6 cmH₂O, PS 12 cmH₂O)

Primary outcomes

  1. Incidence of postoperative desaturation (SpO₂ < 92%)

    Time frame: Within the first 60 minutes after extubation

    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.

Secondary outcomes

  1. Change in Peripheral Oxygen Saturation (SpO₂)

    Time frame: 0-60 minutes post-extubation

    SpO₂ values measured at predefined intervals (1, 3, 5, 10, 15, 30, and 60 minutes) after extubation.

  2. Change in Heart Rate

    Time frame: 0-60 minutes post-extubation

    Heart rate measurements recorded at predefined intervals after extubation.

  3. Change in Systolic and Diastolic Blood Pressure

    Time frame: 0-60 minutes post-extubation

    Systolic and diastolic blood pressure were recorded at predefined intervals after extubation.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Acronym: PPET

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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