2024-513117-12-00尚未招募Phase III and phase IV (Integrated)
Goal-directed low oxygen concentration during anesthesia compared to fixed oxygen concentration: A single blind, phase IV, randomized controlled multicenter trial
Region Vaesterbotten, Umea University3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月29日最近更新:
相关药物
试验速览
- 阶段
- Phase III and phase IV (Integrated)
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.
研究概览
简要总结
To investigate if there is an improvement in postoperative arterial oxygen partial pressure (PaO2) after goal-directed low oxygen concentration during anesthesia compared to the routine use with fixed oxygen concentrations.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults (> 18 years old)
- •The subject has given their written consent to participate in the trial.
- •Be scheduled for abdominal surgery performed at the Departments of Surgery, Urology and Gynecology lasting more than 2 hours.
- •Fall under the American Society of Anesthesia (ASA) Class 1-3.
排除标准
- •Increased risk for difficult intubation during anesthesia (Mallampati score 3-4) or previous documentation of difficult intubation.
- •The inability to understand written or verbal information, thereby hindering the ability to provide informed consent.
- •Obese with a BMI >35 kg/m
- •Participation or recent participation within 30 days in a clinical trial with an investigational medicinal product. Previous participation in this trial.
结局指标
主要结局
Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.
Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.
次要结局
- Change in diffusion capacity for carbon monoxide on day 2 and after 3 months compared to the day preceding surgery (=baseline).
- Change in vital capacity (VC) on day 2 and after 3 months compared to baseline.
- Change in PaO2 and PaCO2 on day 1 and after 3 months compared to baseline.
- Surgical site infections within 30 days of surgery.
- Postoperative recovery using the Postoperative Recovery Profile at discharge and after 3 months
- Hospital length of stay.
- Effect of background variables on outcomes, including age, sex, height, weight, body mass index (BMI), type of surgery, duration of surgery, and type of anesthesia.
研究者
Karl Franklin
Scientific
Region Vaesterbotten
研究点 (3)
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