Feasibility of Delivering Enhanced Recovery After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- ERAS bundle compliance in the first 48hours post-op
研究概览
简要总结
Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society.
The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
详细描述
Why? Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society. These protocols have been demonstrated as safe, though have yet to make it into mainstream practice in the UK. The use of ERPs in Cardiac Surgery has the potential to greatly improve the patient journey and hospital efficiency.
What? The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
Who? All adult patients over the age of 18 years and listed for cardiac surgery will be considered for inclusion in this study.
Where? The study population will be comprised of patients undergoing cardiac surgery at the James Cook University Hospital in Middlesbrough.
How? Study duration will be 6 months, with 80 patients (comprising a control and intervention group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Having Cardiac Surgery
- •Aged 18 years or older at the time of consent
- •Deemed appropriate for ERAS by Surgeon and Anaesthetist
- •Able and willing to provide written informed consent
排除标准
- •Aged 18 years or under
- •Deemed not suitable for ERAS by Surgeon and/or Anaesthetist
研究组 & 干预措施
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Pre-operative Carbohydrate PreLoad drink (Dietary Supplement)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Oral Gabapentin pre-op (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Oral Lansoprazole pre-op (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Intravenous Paracetamol intra-operatively (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Intravenous Dexamethasone intra-operatively (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Intravenous Ondansetron intra-operatively (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Infiltration of surgical wounds with local anaesthetic (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Intravenous Magnesium intra-operatively (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Post-operative Gabapentin analgesia (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Post-operative oral Paracetamol analgesia (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Post-operative Ondansetron anti-emesis (Drug)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Early extubation (Procedure)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Early mobilisation/physiotherapy (Procedure)
ERAS group
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
干预措施: Encourage early oral food intake (Other)
结局指标
主要结局
ERAS bundle compliance in the first 48hours post-op
时间窗: 48hours post op
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 6 out of 10)
次要结局
- Time to mobilisation(0-48hours)
- Post-op pain(24hours)
- Time to extubation(0-24hours)
- Time to oral diet(0-48hours)
- Quality of Recovery(6 weeks post surgery)
研究者
Dr Jim Coates
Clinical Research Fellow in Cardiothoracic Anaesthesia
James Cook University Hospital