Positive-Pressure vs Suction Extubation in Cesarean Patients

NCT07251686 | Completed

• 2 other identifiers: PPETRCT2024Medipol University Ethics
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postoperative Respiratory Complication; Positive pressure; Extubation; Cesarean Section; Anesthesia; Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Peripheral Oxygen Saturation (SpO₂)

  0-60 minutes post-extubation

• Change in Heart Rate

  0-60 minutes post-extubation

• Change in Systolic and Diastolic Blood Pressure

  0-60 minutes post-extubation

Study Arms (2)

Positive-Pressure Extubation (PPET)

EXPERIMENTAL

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

Procedure: Positive Pressure Extubation Technique (PPET)

Negative-Pressure Extubation (NPET)

ACTIVE COMPARATOR

Extubation was performed under continuous suction during cuff deflation, representing the conventional technique.

Procedure: Negative Pressure Extubation Technique (NPET)

Interventions

Negative Pressure Extubation Technique (NPET) PROCEDURE

Extubation performed under continuous suction during cuff deflation.

Negative-Pressure Extubation (NPET)

Positive Pressure Extubation Technique (PPET) PROCEDURE

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

Positive-Pressure Extubation (PPET)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only adult female patients undergoing elective cesarean section under general anesthesia were enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol Mega University Hospital

Istanbul, Bagcılar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• NURDAN YILMAZ

  Istanbul Medipol Mega University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded because all procedures were performed under general anesthesia, and they were unaware of which extubation technique was used. The anesthesiologist performing extubation was not blinded to group allocation. Postoperative oxygenation data were recorded and analyzed by an investigator blinded to the intervention groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: September 1, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)