Enhanced Recovery After Cardiac Surgery

Coronary Artery Disease Clinical Trial

— ERAS  

Official title:

Feasibility of Delivering Enhanced Recovery After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859102
• Other study ID #: IRAS242926
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: November 29, 2019

Study information

• Verified date: September 2019
• Source: James Cook University Hospital
• Contact: Jim C Coates, MBBS
• Phone: 01642854630
• Email: james.coates1[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 29, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Root Dilatation
• Aortic Valve Disease
• Cardiac Surgery
• Coronary Artery Disease
• Mitral Valve Disease
• Tricuspid Valve Disease

Intervention

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.
• Oral Lansoprazole pre-op
One dose of Lansoprazole pre-operatively, 30mg orally.
• Intravenous Paracetamol intra-operatively
One dose of Paracetamol intra-operatively, 1gram intravenous infusion.
• Intravenous Dexamethasone intra-operatively
One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.
• Intravenous Ondansetron intra-operatively
One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous
• Infiltration of surgical wounds with local anaesthetic
Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.
• Intravenous Magnesium intra-operatively
One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.
• Post-operative Gabapentin analgesia
Post-operative oral Gabapentin 300mg, three times daily as an analgesic.
• Post-operative oral Paracetamol analgesia
Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.
• 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.
• 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

Locations

Country	Name	City	State
United Kingdom	James Cook University Hospital	Middlesbrough	Teeside

Sponsors (2)

Lead Sponsor	Collaborator
James Cook University Hospital	Medela AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to extubation	Time taken until patient extubated (ETT) post op (in minutes)	0-24hours
Secondary	Time to mobilisation	First mobilisation with nurse/physiotherapist post-op (in minutes)	0-48hours
Secondary	Time to oral diet	Time until patient first eats post-op (in minutes)	0-48hours
Secondary	Post-op pain	Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)	6hours
Secondary	Post-op pain	Pain scores at 12hours, Numeric scale 0 (no pain) - 10 (severe pain)	12hours
Secondary	Post-op pain	Pain scores at 24hours, Numeric scale 0 (no pain) - 10 (severe pain)	24hours
Secondary	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