Istanbul Medipol Mega University Hospital
Istanbul, Bagcılar, Turkey (Türkiye)
NCT Number: NCT07251686
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
Istanbul, Bagcılar, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Extubation performed under continuous suction during cuff deflation.
Extubation performed under continuous positive airway pressure during cuff deflation (PEEP 6 cmH₂O, PS 12 cmH₂O)
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.
Time frame: 0-60 minutes post-extubation
SpO₂ values measured at predefined intervals (1, 3, 5, 10, 15, 30, and 60 minutes) after extubation.
Time frame: 0-60 minutes post-extubation
Heart rate measurements recorded at predefined intervals after extubation.
Time frame: 0-60 minutes post-extubation
Systolic and diastolic blood pressure were recorded at predefined intervals after extubation.
Medipol University
Other
Impact of Extubation Technique on Postoperative Pulmonary Outcomes: A Randomized Controlled Trial
Acronym: PPET
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.
Published trials that share one or more normalized conditions with this study.
NCT03884543
Postoperative Respiratory Complication
Dresden, Germany
View Trial DetailsNCT06234774
Postoperative Respiratory Complication
View Trial DetailsNCT04736212
Postoperative Respiratory Complication, Respiration Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT04414228
Anesthesia, Hemodynamic Instability
Taipei, Taiwan
View Trial Details