Effects of Pressure Support and Positive End-Expiratory Pressure Added to Deep Breathing Preoxygenation on Gastric Distension in Obese Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time to reach an end-tidal oxygen concentration (EtO₂) of 90%
研究概览
简要总结
Obese patients are at increased risk of low oxygen levels during the induction of general anesthesia. Preoxygenation with a face mask before anesthesia is routinely used to increase oxygen reserves. This study compares three preoxygenation techniques: deep breathing alone, deep breathing with pressure-supported ventilation, and deep breathing with pressure-supported ventilation plus positive end-expiratory pressure (PEEP).
The main goal of the study is to determine how quickly each technique allows patients to reach an adequate level of oxygen in the lungs. In addition, the study evaluates whether these techniques cause gastric distension, which could increase the risk of regurgitation. Gastric ultrasound is used to assess stomach size before and after preoxygenation.
The results of this study will help identify the most effective and safest method of preoxygenation in obese patients undergoing elective surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Scheduled for elective surgery under general anesthesia
- •Able to cooperate with deep breathing during preoxygenation
排除标准
- •Hemodynamic instability
- •Poor cooperation
- •Preoperative oxygen therapy requirement
- •Conditions in which positive pressure ventilation may be harmful (e.g., increased intracranial or intraocular pressure)
- •Pregnancy
- •Emergency surgery
- •Beard (preventing adequate face mask seal)
- •Previous gastric surgery
- •Inability to visualize the gastric antrum by ultrasonography
研究组 & 干预措施
DB (Deep Breathing)
Deep breathing preoxygenation with 100% oxygen at 12 L/min using.
干预措施: Positive End-Expiratory Pressure (Procedure)
DB+PSV
Preoxygenation with deep breathing supported by pressure-supported ventilation (PSV-Pro) with 12 cmH₂O pressure support and 100% oxygen at 12 L/min until EtO₂ reached 90%.
干预措施: Deep Breathing Preoxygenation (Procedure)
DB+PSV+PEEP
Deep breathing preoxygenation supported by PSV-Pro (pressure support 12 cmH₂O) with the addition of PEEP 6 cmH₂O; 100% oxygen at 12 L/min. This arm differs from Arm 2 by the application of PEEP.
干预措施: Pressure Support Ventilation (Procedure)
结局指标
主要结局
Time to reach an end-tidal oxygen concentration (EtO₂) of 90%
时间窗: Periprocedural (during the preoxygenation period, prior to induction of anesthesia)
The time, in seconds, from the start of preoxygenation until the end-tidal oxygen concentration (EtO₂) reached 90%. End-tidal oxygen was measured at 30-second intervals using the anesthesia machine gas analyzer. Reaching EtO₂ 90% was defined as the endpoint of the preoxygenation period.
次要结局
- Heart rate(Periprocedural (baseline and pre-induction))
- Gastric antral cross-sectional area(Periprocedural (baseline and pre-induction))
- Gastric distension score(Periprocedural (baseline and pre-induction))
- Reflux, belching, and discomfort(Periprocedural (baseline and pre-induction))
- Systolic Blood Pressure(Periprocedural (baseline and pre-induction))
- Diastolic Blood Pressure(Pre-induction (baseline and at completion of preoxygenation, defined by EtO₂ reaching 90%))
- Peripheral Oxygen Saturation (SpO₂)(Periprocedural (baseline and pre-induction))
研究者
Cagin Tanriverdi
Principal Investigator
Pamukkale University