Clinical trial NCT03859102: Enhanced Recovery After Cardiac Surgery
Official title: Feasibility of Delivering Enhanced Recovery After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: James Cook University Hospital
Sponsor class: OTHER
Collaborators: name: Medela AG
First posted: 2019-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential prospective cohort study
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: ERAS bundle compliance in the first 48hours post-op
timeFrame: 48hours post op
Secondary outcomes:
measure: Time to extubation
timeFrame: 0-24hours
measure: Time to mobilisation
timeFrame: 0-48hours
measure: Time to oral diet
timeFrame: 0-48hours
measure: Post-op pain
timeFrame: 6hours
measure: Post-op pain
timeFrame: 12hours
measure: Post-op pain
timeFrame: 24hours
measure: Quality of Recovery
timeFrame: 6 weeks post surgery
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: Teeside
Study officials:
affiliation: James Cook University Hospital
name: Jim C Coates, MBBS
role: PRINCIPAL_INVESTIGATOR
References: