Postoperative Mobilization Immediate After Open Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Peripheral oxygen saturation
研究概览
简要总结
Advances in surgical technique have led to a more complex surgery on patients with more serious comorbidities and the risk of postoperative pulmonary complications (PPC) is considerable . The isolated effect of mobilization immediately after surgery has previously not been studied. The aim of the study is to evaluate the effects of immediate mobilization (within 2 hours after arrival to the postoperative recovery unit) after abdominal surgery and also the patients and the staffs experiences of early mobilization.
Methods: A randomized controlled trial will be conducted. A total of 300 Swedish-speaking, adult patients (≥18 years) planned for elective open or robot assisted laparascopic abdominal surgery with an expected anesthetic duration exceeding 2 hours are eligible for consecutive enrollment in the study. Patients who cannot mobilize independently before surgery, will be excluded. Procedure: Randomization to:
- Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside + breathing exercises standardized every hour, with a PEP-device or to
- Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside.
or to 3. No mobilization - laying or sitting in bed with a maximum of 30° elevation of the head rest. No mobilization out of the bed or breathing exercises until discharge or a maximum of 6 hours.
Outcome assessment: The primary outcomes are arterial oxygen pressure (PaO2), and peripheral oxygen saturation (SpO2) over time and between groups. Secondary outcomes are arterial carbon dioxide pressure (PaCO2), pH, bGlu, lactate (arterial blood gas sample) over time and between groups; lung function assessed as forced vital capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow (PEF) by a micro spirometer ( preoperatively and the day after surgery); postoperative pneumonia and total length of stay at the postoperative recovery unit and at the hospital.
After the intervention both patients (n 25) and staff (n 20) will be interviewed about experiences of early mobilization.
Clinical significance: If a fairly simple and cheap intervention, such as mobilization immediately after open abdominal surgery, can lead to imporved oxygen saturation, shortened stay at hospital in total, it should be included as a routine in postoperative care.
详细描述
There are approximately 600 000 surgeries performed each year in Sweden. Advances in surgical technique have led to a more complex surgery on patients with more serious comorbidities. This, in turn, has led to longer operations, which expose patients to longer periods of anesthesia. During anesthesia, muscle relaxant is used, the diaphragm is then relaxed and abdominal contents are pressing against the muscle and lung tissue behind. This in combination with surgery, supine position and immobilization during a longer period of time, has a negative impact on the functional respiratory capacity (FRC) even after the surgery. The ability to cough is eliminated and produced secretion remains in the airways increasing the risk of airway closure. Therefore, the risk of postoperative pulmonary complications (PPC) such as pneumonia, atelectasis (collapsed airways in the lungs) and respiratory insufficiency, is considerable. Mobilization (to sit, stand or walk) is recomended as an intervention to improve and normalize breathing after surgery. However, the isolated effect of mobilization immediately after surgery has previously not been studied.
Hypothesis We hypothesize that immediate mobilization (within 2 hours after arrival at the postoperative recovery unit) after open or robot assisted laporascopic abdominal surgery will affect respiratory function.
Points of inquiry
- Can mobilization or mobilization and breathing exercises (standardized every hour) with a PEP-device, at a pressure of 10-15cmH2O positive expiratory pressure (PEP) affect respiratory function ?
- Can mobilization or mobilization and breathing exercises (PEP) reduce the prevalence of postoperative pneumonia, shorten time at the recovery unit or total length of stay at the hospital?
- How do patients and staff expereience early mobilization after abdominal surgery?
Methods A randomized controlled trial will be conducted to evaluate whether mobilization immediately after open or robot assisted laparascopic abdominal surgery can affect respiratory function.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The interventions were not possible to mask for patients or healthcare professionals at the recovery unit. The research nurses and the physiotherapists, who performed the postoperative spirometry, were blinded to the group randomization. All data were coded, and group assignment was blinded for outcome analyses
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Swedish-speaking, adult patients (≥18 years) planned for elective open or robot assisted laparascopic abdominal surgery with anesthetic time exceeding 2 hours, at Karolinska University Hospital Solna
排除标准
- •Patients who cannot mobilize independently before surgery will be excluded, or if not able to understand instructions.
结局指标
主要结局
Peripheral oxygen saturation
时间窗: 1 year
measured with pulse oximetry
Arterial oxygen saturation
时间窗: 1 year
measured with blood gases
次要结局
- Arterial carbon dioxide(1 year)
- pH, lactate and Bglu(1 year)
- forced expiratory volume in one second (FEV1)(1 year)
- forced vital capacity (FVC)(1 year)
- Peak expiratory flow (PEF)(1 year)
- Total length of stay at hospital(1 year)
- postoperative pulmonary complications(1 year)
研究者
Malin Nygren-Bonnier
RPT, PhD, Senior lecturer
Karolinska Institutet