An Algorithmic Approach to Preoxygenation: Stepwise Addition of Pressure Support and Positive End-expiratory Pressure When Tidal Volume Breathing is Inadequate. A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Adequate preoxygenation.
研究概览
简要总结
The aim of this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. The main question it aims to answer is:
- Will the proportion of patients receiving preoxygenation increase?
- Will the duration of preoxygenation decrease?
Participants will;
- 200 patients who were planned to undergo general anesthesia for elective surgeries
- aged between 18 and 65 years
- ASA 1-2 physical status
- ETO2 <90% at the end of the 3rd minute with spontaneous tidal volume breathing
详细描述
The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).
When adequate preoxygenation was achieved, the duration of preoxygenation, SpO2, end-tidal carbon dioxide (ETCO2), arterial blood pressures and heart rate values were recorded. Any adverse effects such as discomfort or gastric distension were noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgeries general anaesthesia was planned for a patient aged 18-65 years with ASA 1-2 physical condition.
排除标准
- •Haemodynamically unstable, preoperative oxygen support such as increased intracranial or intraocular pressure, to be operated on by thoracic surgery have conditions in which positive pressure ventilation may be indirectly harmful, BMI≥35 kg/m2, pregnant, undergoing emergency surgery and causing leakage in mask ventilation bearded male patients were not included in the study.
研究组 & 干预措施
Group TVB
Group TVB patients who could not reach 90% ETO2 at the end of the 3rd minute were continued with tidal volume breathing.
干预措施: Group TVB (Procedure)
Group PSV
Group PSV received 6 cm H2O positive pressure ventilation.
干预措施: Group PSV (Procedure)
Group PSV+PEEP
In addition to 6 cmH2O pressure support, 4 cmH2O end-expiratory positive pressure support was added to the patients included in Group PEEP.
干预措施: Group PSV (Procedure)
Group PSV+PEEP
In addition to 6 cmH2O pressure support, 4 cmH2O end-expiratory positive pressure support was added to the patients included in Group PEEP.
干预措施: Group PSV+PEEP (Procedure)
结局指标
主要结局
Adequate preoxygenation.
时间窗: The moment when the end-tidal oxygen value of patients with insufficient preoxygenation at the end of the third minute with spontaneous tidal volume breathing is 90 and above.
The moment of ensuring adequate preoxygenation when the end-tidal oxygen value is 90 and above.
次要结局
- Adverse effects(Within 5 min until target preoxygenation is reached.)
研究者
Cagin Tanriverdi
Specialist, Department of Anesthesiology and Reanimation, Principal Investigator
Pamukkale University