Evaluating the Feasibility and Safety of Using Nasal High Flow Oxygen for Five Days Postoperatively to Reduce Respiratory Complications After Oesophagectomy for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of respiratory complications within 30 days after surgery
研究概览
简要总结
The use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied.
Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. Physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery.
This study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. The results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.
详细描述
Respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. The primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. Technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. Other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. These data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. The rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. This may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Over 18 years old
- •Undergoing Ivor-Lewis (2-stage) oesophagectomy
- •Successfully extubated within 4 hours after surgery
排除标准
- •History of bullous emphysematous disease
- •Lack of capacity to consent
- •Significant air leak during surgery
- •Incurable disease found at surgery leading to no surgical resection
- •Failure of extubation and spontaneous breathing within 4 hours after surgery
结局指标
主要结局
Rate of respiratory complications within 30 days after surgery
时间窗: 30 days
including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism.
次要结局
- Recruitment rate(90 days)
- 30 day mortality(30 days)
- The proportion of blood gases performed on time(5 days)
- The proportion of missing results(5 days)
- 90 day mortality(90 days)
- 90 day respiratory complication rate(90 days)