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Enhanced Recovery After Cardiac Surgery (ERAS)

Primary Purpose

Cardiac Surgery, Coronary Artery Disease, Aortic Valve Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pre-operative Carbohydrate PreLoad drink
Oral Gabapentin pre-op
Oral Lansoprazole pre-op
Intravenous Paracetamol intra-operatively
Intravenous Dexamethasone intra-operatively
Intravenous Ondansetron intra-operatively
Infiltration of surgical wounds with local anaesthetic
Intravenous Magnesium intra-operatively
Post-operative Gabapentin analgesia
Post-operative oral Paracetamol analgesia
Post-operative Ondansetron anti-emesis
Early extubation
Early mobilisation/physiotherapy
Encourage early oral food intake
Sponsored by
James Cook University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring Enhanced recovery after Surgery, ERAS, Enhanced Recovery after Cardiac Surgery, Cardiac Surgery, Coronary Artery Bypass graft, Aortic Valve Surgery, Mitral Valve Surgery, Aortic Root Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James Cook University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

ERAS Control/non-ERAS group

ERAS group

Arm Description

Standard usual care after cardiac surgery.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2018
Last Updated
September 25, 2019
Sponsor
James Cook University Hospital
Collaborators
Medela AG
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1. Study Identification

Unique Protocol Identification Number
NCT03859102
Brief Title
Enhanced Recovery After Cardiac Surgery
Acronym
ERAS
Official Title
Feasibility of Delivering Enhanced Recovery After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
November 29, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James Cook University Hospital
Collaborators
Medela AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease, Aortic Root Dilatation
Keywords
Enhanced recovery after Surgery, ERAS, Enhanced Recovery after Cardiac Surgery, Cardiac Surgery, Coronary Artery Bypass graft, Aortic Valve Surgery, Mitral Valve Surgery, Aortic Root Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS Control/non-ERAS group
Arm Type
No Intervention
Arm Description
Standard usual care after cardiac surgery.
Arm Title
ERAS group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pre-operative Carbohydrate PreLoad drink
Intervention Description
Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.
Intervention Type
Drug
Intervention Name(s)
Oral Gabapentin pre-op
Intervention Description
One dose of Gabapentin pre-operatively, 300mg orally.
Intervention Type
Drug
Intervention Name(s)
Oral Lansoprazole pre-op
Intervention Description
One dose of Lansoprazole pre-operatively, 30mg orally.
Intervention Type
Drug
Intervention Name(s)
Intravenous Paracetamol intra-operatively
Intervention Description
One dose of Paracetamol intra-operatively, 1gram intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Intravenous Dexamethasone intra-operatively
Intervention Description
One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.
Intervention Type
Drug
Intervention Name(s)
Intravenous Ondansetron intra-operatively
Intervention Description
One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous
Intervention Type
Drug
Intervention Name(s)
Infiltration of surgical wounds with local anaesthetic
Intervention Description
Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.
Intervention Type
Drug
Intervention Name(s)
Intravenous Magnesium intra-operatively
Intervention Description
One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.
Intervention Type
Drug
Intervention Name(s)
Post-operative Gabapentin analgesia
Intervention Description
Post-operative oral Gabapentin 300mg, three times daily as an analgesic.
Intervention Type
Drug
Intervention Name(s)
Post-operative oral Paracetamol analgesia
Intervention Description
Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.
Intervention Type
Drug
Intervention Name(s)
Post-operative Ondansetron anti-emesis
Intervention Description
Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.
Intervention Type
Procedure
Intervention Name(s)
Early extubation
Intervention Description
Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.
Intervention Type
Procedure
Intervention Name(s)
Early mobilisation/physiotherapy
Intervention Description
Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.
Intervention Type
Other
Intervention Name(s)
Encourage early oral food intake
Intervention Description
Patients will be encouraged to start eating as soon as possible post-operatively
Primary Outcome Measure Information:
Title
ERAS bundle compliance in the first 48hours post-op
Description
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 6 out of 10)
Time Frame
48hours post op
Secondary Outcome Measure Information:
Title
Time to extubation
Description
Time taken until patient extubated (ETT) post op (in minutes)
Time Frame
0-24hours
Title
Time to mobilisation
Description
First mobilisation with nurse/physiotherapist post-op (in minutes)
Time Frame
0-48hours
Title
Time to oral diet
Description
Time until patient first eats post-op (in minutes)
Time Frame
0-48hours
Title
Post-op pain
Description
Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)
Time Frame
6hours
Title
Post-op pain
Description
Pain scores at 12hours, Numeric scale 0 (no pain) - 10 (severe pain)
Time Frame
12hours
Title
Post-op pain
Description
Pain scores at 24hours, Numeric scale 0 (no pain) - 10 (severe pain)
Time Frame
24hours
Title
Quality of Recovery
Description
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.
Time Frame
6 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim C Coates, MBBS
Phone
01642854630
Email
james.coates1@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian Mellor, MBBS
Phone
01642850850
Email
adrian.mellor@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim C Coates, MBBS
Organizational Affiliation
James Cook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
Teeside
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim C Coates, MBBS
Phone
01642854630
Email
james.coates1@nhs.net
First Name & Middle Initial & Last Name & Degree
Jim C Coates, MBBS
First Name & Middle Initial & Last Name & Degree
Adrian Mellor, MBBS
First Name & Middle Initial & Last Name & Degree
Sarah Round, MBBS
First Name & Middle Initial & Last Name & Degree
Jonathan Brand, MBBS
First Name & Middle Initial & Last Name & Degree
Enoch Akuowah, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Recovery After Cardiac Surgery

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