Modified Rapid Sequence Induction in Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Amount of air aspirated with a gastric tube
研究概览
简要总结
This study investigates the effect of 4 different methods of rapid sequence induction (RSI) in morbidly obese patients on the amount of air insufflation into the stomach.
详细描述
100 adult patients with a body mass index > 40 undergoing elective laparoscopic surgery will be included. Patients with a history of previous bariatric surgery or with an anticipated difficult airway will be excluded.
The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.
All groups will receive standardized preoperative continuous positive airway pressure (CPAP) therapy.
In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed after 1 minute. No bag mask ventilation will be performed in-between.
Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3 minutes. The same induction agents as in group one will be administered. PEEP via facemask will be continued for one minute and tracheal intubation will be performed.
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 (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 40
- •American Society of Anesthesiology Class 1-3
- •Elective laparoscopic surgery
排除标准
- •Pregnant or breastfeeding patients
- •Previous bariatric surgery
- •Anticipated difficult airway
研究组 & 干预措施
t-RSI
Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Rapid sequence induction t-RSI (Procedure)
t-RSI
Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Anesthetics (Drug)
t-RSI
Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Aspiration of gastric air via nasogastric tube (Diagnostic Test)
t-RSI
Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Impression of gastric inflation at laparoscopy. (Diagnostic Test)
t-RSI
Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Arterial blood gas (Diagnostic Test)
m-RSI-PEEP
Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Rapid sequence induction m-RSI-PEEP (Procedure)
m-RSI-PEEP
Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Anesthetics (Drug)
m-RSI-PEEP
Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Aspiration of gastric air via nasogastric tube (Diagnostic Test)
m-RSI-PEEP
Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Impression of gastric inflation at laparoscopy. (Diagnostic Test)
m-RSI-PEEP
Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Arterial blood gas (Diagnostic Test)
m-RSI-vent
Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Rapid sequence induction m-RSI-vent (Procedure)
m-RSI-vent
Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Anesthetics (Drug)
m-RSI-vent
Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Aspiration of gastric air via nasogastric tube (Diagnostic Test)
m-RSI-vent
Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Impression of gastric inflation at laparoscopy. (Diagnostic Test)
m-RSI-vent-cric
Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Anesthetics (Drug)
m-RSI-vent
Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Arterial blood gas (Diagnostic Test)
m-RSI-vent-cric
Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: m-RSI-vent-cric (Procedure)
m-RSI-vent-cric
Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Cricoid Pressure (Procedure)
m-RSI-vent-cric
Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Aspiration of gastric air via nasogastric tube (Diagnostic Test)
m-RSI-vent-cric
Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Impression of gastric inflation at laparoscopy. (Diagnostic Test)
m-RSI-vent-cric
Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
干预措施: Arterial blood gas (Diagnostic Test)
结局指标
主要结局
Amount of air aspirated with a gastric tube
时间窗: at the beginning of the laparoscopy
The amount of air that can be aspirated via a nasogastric tube at the beginning of laparoscopy. A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
次要结局
- partial pressure of oxygen in arterial blood (paO2)(before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated)
- Gastric inflation(at the beginning of laparoscopy)
研究者
Thomas Hamp
Univ. Prof. Dr.
Medical University of Vienna