The Cost in Oxygen of Surgical Trauma (CO2ST) - a Feasibility Study of the Non-invasive Measurement of Oxygen Delivery and Consumption After Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postoperative morbidity score (POMS)
研究概览
简要总结
The investigators will examine the relationship between post-operative oxygen consumption (using non-invasive measurement technology ) and complications in patients having contemporary major abdominal surgery. The investigators hypothesis is that major surgery may trigger a physiological stress response that results in an increase in post-operative metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen delivery (DO2).
- To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2) using indirect calorimetry in a cohort of patients
- To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the same cohort using non-invasive measures of cardiac output, oxygen saturation and haemoglobin (pulse wave transit time and co-oximetry techniques)
详细描述
Prospective observational study of non-invasive measurements of V̇O2 and DO2 pre-operatively and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing elective major abdominal surgery (both open and laparoscopic) with a pre-operative cardiopulmonary exercise testing (CPET).
As pilot work examining the relationship between post-operative oxygen consumption and complications in patients having contemporary major abdominal surgery , the investigators need to define and grade the severity of complications. The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.
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
- •Male and female patients aged 18 or over.
- •Undergoing elective major open or laparoscopic abdominal surgery.
排除标准
- •Refusal to participate
- •Requirement for post-operative ventilation
- •Requirement of inspired oxygen concentrations (FiO2) > 28% to maintain oxygen saturations ≥ 90%.
结局指标
主要结局
postoperative morbidity score (POMS)
时间窗: Day 5 post surgery
The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.
次要结局
- Length of hospital stay(estimated average length of hospital stay of 5 - 7 days)
- Unplanned admission to critical care.(Participants will be followed for the duration of hospital stay, an expected average of 5 - 7 days)
- Returns to the operating theatre(Number of events during Hospital admission (estimated average length of hospital stay of 5 - 7 days))
- Hospital readmission(Within 30 days of discharge from hospital)
- Mortality(Up to 30 days following hospital discharge)