Enhanced Recovery After Cardiac Surgery (ERAS)

Feasibility of Delivering Enhanced Recovery After Cardiac Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Aortic Valve Disease; Cardiac Surgery; Mitral Valve Disease; Tricuspid Valve Disease; Aortic Root Dilatation
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Teeside
    • Middlesbrough, Teeside, United Kingdom, TS4 3BW
      • Recruiting
      • James Cook University Hospital
      • Contact: Jim C Coates, MBBS; Phone Number: 01642854630; Email: james.coates1@nhs.net
      • Principal Investigator: Jim C Coates, MBBS
      • Sub-Investigator: Adrian Mellor, MBBS
      • Sub-Investigator: Sarah Round, MBBS
      • Sub-Investigator: Jonathan Brand, MBBS
      • Sub-Investigator: Enoch Akuowah, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Aged 18 years or under
• Deemed not suitable for ERAS by Surgeon and/or Anaesthetist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to extubation	Time taken until patient extubated (ETT) post op (in minutes)	0-24hours
Time to mobilisation	First mobilisation with nurse/physiotherapist post-op (in minutes)	0-48hours
Time to oral diet	Time until patient first eats post-op (in minutes)	0-48hours
Post-op pain	Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)	6hours
Post-op pain	Pain scores at 12hours, Numeric scale 0 (no pain) - 10 (severe pain)	12hours
Post-op pain	Pain scores at 24hours, Numeric scale 0 (no pain) - 10 (severe pain)	24hours
Quality of Recovery	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.	6 weeks post surgery

Collaborators and Investigators

• Sponsor: James Cook University Hospital
• Collaborators: Medela AG
• Investigators: Principal Investigator: Jim C Coates, MBBS, James Cook University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): November 29, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac Surgery; ERAS; Mitral Valve Surgery; Aortic Valve Surgery; Enhanced recovery after Surgery; Enhanced Recovery after Cardiac Surgery; Coronary Artery Bypass graft; Aortic Root Surgery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Valve Diseases; Coronary Disease; Coronary Artery Disease; Aortic Valve Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antipruritics; Dexamethasone; Anesthetics; Gabapentin; Dexlansoprazole; Lansoprazole; Acetaminophen; Anesthetics, Local; Ondansetron
• Other Study ID Numbers: IRAS242926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No