Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
- Conditions
- Coronary StenosisCoronary Artery Disease
- Interventions
- Behavioral: Premedication visitDrug: Preoperative periodOther: Postoperative periodDrug: Intraoperative period
- Registration Number
- NCT03956420
- Lead Sponsor
- Silesian University of Medicine
- Brief Summary
It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.
Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.
In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).
- Detailed Description
Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:
* preoperative preparation (comprehensive information, premedication, hydration),
* haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
* occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
* demand for painkillers in the postoperative period, after introducing the preemptive strategy,
* incidence of postoperative delirium,
* time to recovery of the normal bowel function (nausea, vomiting),
* possibility of early mobilisation on the first day after surgery,
* patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery).
- Left ventricular ejection fraction above 35% (EF ≥ 35%).
- The operation was performed in a planned mode.
- Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin.
- Neurological disorders, stroke with persistent symptoms, dementia.
- Chronic lung disease with hypoxia and the need for regular medication.
- Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers.
- Emergency surgery, reoperation.
- Return to the operating room regardless of the reason (resternotomy).
- Perioperative infarction with circulatory destabilization.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group Postoperative period Implemented ERAS (Early Recovery After Surgery) elements Study group Premedication visit Implemented ERAS (Early Recovery After Surgery) elements Study group Preoperative period Implemented ERAS (Early Recovery After Surgery) elements Study group Intraoperative period Implemented ERAS (Early Recovery After Surgery) elements
- Primary Outcome Measures
Name Time Method ERAS bundle compliance in the first 72 hours post-op 72 hours post operation Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10)
Shorter Length Of Hospitalization (LOH) up to 4 weeks after operation Total amount of days spent in hospital
- Secondary Outcome Measures
Name Time Method Time to drink 0-72 hours Time until patient first drinks post extubation (in hours)
Time to eating 0-72 hours Time until patient first eats post extubation (in hours)
Time to bowel movement in hours after extubation, up to 1 week Hours elapsed to event
Incidence of postoperative delirium in hours after extubation, up to 72 hours Delirium Screening according to Nursing Delirium Screening Scale, Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe.
Positive Nu-DESC is score ≥2, maximum total score is 10Preoperative anxiety on admission to the operating unit Assessment of patient's emotional status according to Anxiety Likert Scale (consisted of five evenly spaced numbers each anchored to a level of anxiety: 1="not at all anxious," 2="a little anxious," 3="moderately anxious," 4="very anxious," 5="extremely anxious)
Time to extubation 0 -72 hours Time taken until patient extubated post operation (in hours)
Assessment of postoperative pain 0-24 hours Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)
Incidence of postoperative nausea and vomiting At moment 0, 3, 6, 12 and 24 hours after extubation To calculate the PONV Impact Scale score, add the numerical responses to questions 1 and 2. A PONV Impact Scale score of ≥5 defines clinically important PONV (Q1. Have you vomited: 0. No
1. Once
2. Twice
3. Three or more times Q2. Have you experienced a feeling of nausea :0. Not at all
1. Sometimes 2. Often or most of the time 3. All of the time)Postoperative complications up to 2 weeks after surgery Rate measurement
Time to mobilisation 0-72 hours First mobilisation with nurse/physiotherapist post-op (in hours)
Trial Locations
- Locations (1)
Upper-Silesian Medical Centre of the Silesian Medical University
🇵🇱Katowice, Polska, Poland