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临床试验/NCT04747535
NCT04747535Unknown不适用

Continuous Positive Airway Pressure After Abdominal Surgery -A Randomized Controlled Trial

Umeå University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年5月10日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl A Franklin

Professor

Umeå University

研究点 (2)

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