Anesthesia, General, Atelectasis, Extubation, Hypoxia, Postoperative Respiratory Complication
Conditions
Keywords
Postoperative Respiratory Complication, Positive pressure, Extubation, Cesarean Section, Anesthesia, Hypoxia
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.
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.
Interventions
PROCEDURENegative Pressure Extubation Technique (NPET)
Extubation performed under continuous suction during cuff deflation.
PROCEDUREPositive Pressure Extubation Technique (PPET)
Extubation performed under continuous positive airway pressure during cuff deflation (PEEP 6 cmH₂O, PS 12 cmH₂O)
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative desaturation (SpO₂ < 92%) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate | 0-60 minutes post-extubation | Heart rate measurements recorded at predefined intervals after extubation. |
| Change in Peripheral Oxygen Saturation (SpO₂) | 0-60 minutes post-extubation | SpO₂ values measured at predefined intervals (1, 3, 5, 10, 15, 30, and 60 minutes) after extubation. |
| Change in Systolic and Diastolic Blood Pressure | 0-60 minutes post-extubation | Systolic and diastolic blood pressure were recorded at predefined intervals after extubation. |
Countries
Turkey (Türkiye)
Outcome results
None listed