Continuous Positive Airway Pressure After Abdominal Surgery -A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Arterial oxygen partial pressure
研究概览
简要总结
This is a randomized controlled trial with an allocation ratio of 1:1. Half the patients are randomized to continuous positive airway pressure (CPAP) and half to routine medical care. Included are one hundred and twenty patients aged 18-80 years plus patients with ongoing CPAP scheduled for abdominal surgery at Umeå university hospital. The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery. Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery. PaO2 and PaCO2 are recorded from blood gas measurements obtained from the radial artery. Percentage of nocturnal hypoxia defined as the percentage of oxygen saturation during 90% of the second postoperative night. Tolerance to CPAP measured by the number of hours used CPAP. Side effects related to CPAP. All patients are examined with a simplified sleep apnea examination (Noxturnal T3, Res Med) the night before surgery.
Patients in the CPAP treated group are given an auto-CPAP with a minimum pressure of 5 cm and a maximum pressure of 10 cm. They will be treated with CPAP for at least 2 hours immediately after surgery and during the first two postoperative nights. Oxygen is supplied to CPAP if oxygen saturation falls below 90%. Patients in the control group receives standard treatment and supplemental oxygen if oxygen saturation falls below 90%. In a third arm, we will include patients who already are using CPAP at night at home for previously diagnosed obstructive sleep apnea. are instructed to use CPAP for 2 hours immediately after surgery and subsequent nights during hospital stay.
详细描述
Theory Research question: Does nasal CPAP abolish postoperative hypoxia and lung function decline after abdominal surgery?
Methods This is a randomized controlled trial with an allocation ratio of 1:1. Half of the patients are randomized to CPAP and half to routine medical care. Randomization is generated by a computer program and handled by a person outside the study. Randomization procedure is documented by the contact person and in the patient's study protocol.
Include are one hundred and twenty patients age 18-80 years old, scheduled for abdominal surgery at Umeå university hospital. Excluded are patients with American Society of Anesthesia (ASA) class 2-3 and patients with cognitive impairment or dementia, unable to participate. Patients with ongoing CPAP treatment are not randomized. Instead, they form a separate group with ongoing CPAP after surgery
The primary outcome is oxygen partial pressure (PaO2) measured on postoperative day 2 compared with the day before surgery.
Secondary outcomes include diffusion capacity for carbon-monoxide, vital capacity, FEV1 and carbon-dioxide partial pressure (PaCO2) on postoperative day 2 compared with the day before surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age 18-80 years) scheduled for elective abdominal surgery
- •Must be able to tolerate nasal CPAP
排除标准
- •American Society Anesthesia (ASA) Class 3-
- •Cognitive impairment or dementia
结局指标
主要结局
Arterial oxygen partial pressure
时间窗: Difference in change from baseline before surgery to follow-up at postoperative day 2
Difference in PaO2
次要结局
- Diffusion capacity for carbon monoxide(Difference in change from baseline before surgery to follow-up at postoperative day 2)
- Forced vital capacity (FVC)(Difference in change from baseline before surgery to follow-up at postoperative day 2)
- Forced expiratory volume in one second (FEV1)(Difference in change from baseline before surgery to follow-up at postoperative day 2)
- PaCO2(Difference in change from baseline before surgery to follow-up at postoperative day 2)
- time of hypoxia with SaO2 <90%(During postoperative night 2)
- Side effects of CPAP(From day of surgery to the second postoperative day)
- CPAP compliance(From day of surgery to the second postoperative day)
- Sleep apnea(From day of surgery to the second postoperative day)
