ERAS: Enhanced Recovery After Cardiac Surgery

Sponsor

James Cook University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03859102

Collaborator

Medela AG (Industry)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Tricuspid Valve Disease Aortic Root Dilatation	Dietary Supplement: Pre-operative Carbohydrate PreLoad drink Drug: Oral Gabapentin pre-op Drug: Oral Lansoprazole pre-op Drug: Intravenous Paracetamol intra-operatively Drug: Intravenous Dexamethasone intra-operatively Drug: Intravenous Ondansetron intra-operatively Drug: Infiltration of surgical wounds with local anaesthetic Drug: Intravenous Magnesium intra-operatively Drug: Post-operative Gabapentin analgesia Drug: Post-operative oral Paracetamol analgesia Drug: Post-operative Ondansetron anti-emesis Procedure: Early extubation Procedure: Early mobilisation/physiotherapy Other: Encourage early oral food intake	N/A

Detailed Description

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Sequential prospective cohort studySequential prospective cohort study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of Delivering Enhanced Recovery After Cardiac Surgery

Actual Study Start Date :

Dec 17, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Nov 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: ERAS Control/non-ERAS group Standard usual care after cardiac surgery.
Experimental: 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.	Dietary Supplement: Pre-operative Carbohydrate PreLoad drink Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery. Drug: Oral Gabapentin pre-op One dose of Gabapentin pre-operatively, 300mg orally. Drug: Oral Lansoprazole pre-op One dose of Lansoprazole pre-operatively, 30mg orally. Drug: Intravenous Paracetamol intra-operatively One dose of Paracetamol intra-operatively, 1gram intravenous infusion. Drug: Intravenous Dexamethasone intra-operatively One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous. Drug: Intravenous Ondansetron intra-operatively One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous Drug: Infiltration of surgical wounds with local anaesthetic Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg. Drug: Intravenous Magnesium intra-operatively One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes. Drug: Post-operative Gabapentin analgesia Post-operative oral Gabapentin 300mg, three times daily as an analgesic. Drug: Post-operative oral Paracetamol analgesia Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily. Drug: Post-operative Ondansetron anti-emesis Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required. Procedure: Early extubation Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe. Procedure: Early mobilisation/physiotherapy Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively. Other: Encourage early oral food intake Patients will be encouraged to start eating as soon as possible post-operatively

Arm

Intervention/Treatment

No Intervention: ERAS Control/non-ERAS group

Standard usual care after cardiac surgery.

Experimental: 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.

Dietary Supplement: Pre-operative Carbohydrate PreLoad drink

Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.

Drug: Oral Gabapentin pre-op

One dose of Gabapentin pre-operatively, 300mg orally.

Drug: Oral Lansoprazole pre-op

One dose of Lansoprazole pre-operatively, 30mg orally.

Drug: Intravenous Paracetamol intra-operatively

One dose of Paracetamol intra-operatively, 1gram intravenous infusion.

Drug: Intravenous Dexamethasone intra-operatively

One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.

Drug: Intravenous Ondansetron intra-operatively

One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous

Drug: Infiltration of surgical wounds with local anaesthetic

Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.

Drug: Intravenous Magnesium intra-operatively

One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.

Drug: Post-operative Gabapentin analgesia

Post-operative oral Gabapentin 300mg, three times daily as an analgesic.

Drug: Post-operative oral Paracetamol analgesia

Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.

Drug: Post-operative Ondansetron anti-emesis

Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.

Procedure: Early extubation

Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.

Procedure: Early mobilisation/physiotherapy

Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.

Other: Encourage early oral food intake

Patients will be encouraged to start eating as soon as possible post-operatively

Outcome Measures

Primary Outcome Measures

ERAS bundle compliance in the first 48hours post-op [48hours post op]
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 6 out of 10)

Secondary Outcome Measures

Time to extubation [0-24hours]
Time taken until patient extubated (ETT) post op (in minutes)
Time to mobilisation [0-48hours]
First mobilisation with nurse/physiotherapist post-op (in minutes)
Time to oral diet [0-48hours]
Time until patient first eats post-op (in minutes)
Post-op pain [6hours]
Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)
Post-op pain [12hours]
Pain scores at 12hours, Numeric scale 0 (no pain) - 10 (severe pain)
Post-op pain [24hours]
Pain scores at 24hours, Numeric scale 0 (no pain) - 10 (severe pain)
Quality of Recovery [6 weeks post surgery]
Quantification of patient quality of recovery. Using Q-o-R 15 Scale internationally validated scale. This allows the patient to report on a numerical scale from 0 (not at all) to 10 (all of the time); the patients scores on aspects of recovery such as pain at rest, pain on movement, quality of sleep, presence of nausea and vomiting, feeling supported by medical staff.