Postoperative High-flow Nasal Oxygenation After High-risk Surgery in the Frail Adult
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Frequency of postoperative pulmonary complications (PPC) the first seven days after high-risk abdominal or non-cardiac thoracic surgery in high-risk patients with high-flow nasal oxygen or conventional oxygen therapy in the immediate postoperative period
研究概览
简要总结
High flow nasal oxygen (HFNO) in the immediate postoperative period has been demonstrated to reduce the risk of postoperative pulmonary complications (PPC) after cardiothoracic surgery. In specific groups of patients such as the obese and after upper abdominal surgery the results are contradictive. However, there is lack of evidence if HFNO in the general high-risk patient after abdominal and non-cardiac thoracic surgery can reduce the prevalence of PPC, hypoxaemia and escalation of therapy. Therefore, the investigators aim to compare the use of HFNO with conventional oxygen therapy (COT) in high-risk patients after abdominal and non-cardiac thoracic surgery regarding postoperative pulmonary complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) scheduled for elective abdominal (laparotomy or laparoscopy), open abdominal vascular or non-cardiac thoracic surgery under general anaesthesia with an estimated duration over 3 hours.
- •Meeting at least two of the following criteria:
- •Age > 65 years
- •Preoperative SpO2 <95 %
- •Scheduled for lobectomy or pulmonary segment resection
- •Respiratory tract infection the last month
- •Preoperative anaemia (Hb <100) or severe hypoalbuminemia (<20 g/L)
- •Current smoker or previous smoker with >30 packyears
- •Pulmonary disease or OSAS
- •Heart failure
- •Clinical frailty (CFS 4)
排除标准
- •Not suitable for postoperative HFNO, as decided by a study member or the anaesthetist in charge (such as total nasal obstruction, skull fracture, facial injuries)
- •Pregnancy
- •Not able to understand the study information or sign an informed consent.
- •Not able to participate with the treatment postoperatively
- •Planned for delayed extubation in the intensive care
- •Preoperative non-invasive ventilation due to respiratory failure or a higher level of care than a regular ward
研究组 & 干预措施
HFNO
Group of patients receiving HFNO postoperatively
干预措施: High Flow Oxygen (Combination Product)
Conventional oxygen therapy (COT)
Group of patients receiving conventional oxygen therapy postoperatively
干预措施: Oxygen (Combination Product)
结局指标
主要结局
Frequency of postoperative pulmonary complications (PPC) the first seven days after high-risk abdominal or non-cardiac thoracic surgery in high-risk patients with high-flow nasal oxygen or conventional oxygen therapy in the immediate postoperative period
时间窗: Up to 7 days after surgery
次要结局
- Lowest SpO2 the first 2 and 24 h after randomisation(24 hours after randomisation)
- Desaturation (SpO2 <90%) the first 2 or 4 and under 24 hours after randomisation(First 24 hours after randomisation)
- Lowest PaO2/FiO2 ratio during the intervention period(Maximum 4 hours after start of intervention postoperatively)
- Subjective patient comfort (visual scale 0-10)(Maximum 4 hours after start of intervention)
- Length of stay (LOS) in the postoperative unit(Up to 7 days after surgery)
- Length of stay in hospital(From surgery up until 30 days after surgery)
- Mortality in hospital(Up until 30 days after surgery)
- 30-days mortality(30 days after surgery)
- Healthy days at home 30 days after surgery(30 days postoperatively)