Impact of Extubation Technique on Postoperative Pulmonary Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of postoperative desaturation (SpO₂ < 92%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients aged 18 to 45 years.
- •Scheduled for elective cesarean delivery under general anesthesia.
- •Ability to provide written informed consent
排除标准
- •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.
研究组 & 干预措施
Positive-Pressure Extubation (PPET)
Extubation was performed under continuous positive airway pressure (PEEP 6 cmH₂O, PS 12 cmH₂O) during cuff deflation.
干预措施: Positive Pressure Extubation Technique (PPET) (Procedure)
Negative-Pressure Extubation (NPET)
Extubation was performed under continuous suction during cuff deflation, representing the conventional technique.
干预措施: Negative Pressure Extubation Technique (NPET) (Procedure)
结局指标
主要结局
Incidence of postoperative desaturation (SpO₂ < 92%)
时间窗: 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.
次要结局
- 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)
研究者
NURDAN YILMAZ
Assistant Professor
Medipol University