Aortic Root Dilatation, Aortic Valve Disease, Cardiac Surgery, Coronary Artery Disease, Mitral Valve Disease, Tricuspid Valve Disease
Conditions
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
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)
Interventions
DIETARY_SUPPLEMENTPre-operative Carbohydrate PreLoad drink
Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.
One dose of Gabapentin pre-operatively, 300mg orally.
DRUGOral Lansoprazole pre-op
One dose of Lansoprazole pre-operatively, 30mg orally.
DRUGIntravenous Paracetamol intra-operatively
One dose of Paracetamol intra-operatively, 1gram intravenous infusion.
DRUGIntravenous Dexamethasone intra-operatively
One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.
DRUGIntravenous Ondansetron intra-operatively
One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous
DRUGInfiltration of surgical wounds with local anaesthetic
Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.
DRUGIntravenous Magnesium intra-operatively
One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.
DRUGPost-operative Gabapentin analgesia
Post-operative oral Gabapentin 300mg, three times daily as an analgesic.
DRUGPost-operative oral Paracetamol analgesia
Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.
DRUGPost-operative Ondansetron anti-emesis
Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.
PROCEDUREEarly extubation
Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.
PROCEDUREEarly mobilisation/physiotherapy
Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.
OTHEREncourage early oral food intake
Patients will be encouraged to start eating as soon as possible post-operatively
Sponsors
Medela AG
James Cook University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential prospective cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Countries
United Kingdom
Contacts
Primary ContactJim C Coates, MBBS
Backup ContactAdrian Mellor, MBBS
Outcome results
None listed