Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000060640
Ethics application status
Approved
Date submitted
16/12/2022
Date registered
17/01/2023
Date last updated
8/05/2023
Date data sharing statement initially provided
17/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fast-track cardiac anaesthesia for coronary artery bypass graft surgery.
Scientific title
Fast-Track Cardiac Anesthesia using Multimodal Analgesia Improves Postoperative Outcomes in Coronary Artery Bypass Grafting: An Observational Study
Secondary ID [1] 308628 0
None
Universal Trial Number (UTN)
U1111-1286-1923
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative recovery 328530 0
Post-operative pain 328531 0
Coronary artery bypass 328562 0
Condition category
Condition code
Anaesthesiology 325548 325548 0 0
Pain management
Cardiovascular 325549 325549 0 0
Coronary heart disease
Surgery 325550 325550 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective analysis of patients who underwent primary coronary artery bypass
grafting (CABG) surgery via midline sternotomy who were managed by a fast-track protocol (fast-track group) or via usual care (usual care group). All data will be collected from patient electronic medical records, with no additional involvement by the participant required

Patients who undergo primary CABG surgery via midline sternotomy between February 2019 and February 2022 in Victoria will be screened.

Fast track cardiac anaesthesia is a program using methadone with non-opioid adjuvant infusions (magnesium, ketamine, lidocaine, and dexmedetomidine) in patients undergoing CABG.

The following data will be collected for each patient:-
1. Baseline patient characteristics
2. Duration of anaesthesia and cardiopulmonary bypass
3. Total mechanical ventilation time in hours
4. Number of patients who have been successfully extubated within four postoperative hours
5. Pain scores within the first 48 hours postoperatively
6. Total intravenous (IV) opioid requirements within the first 24 and 48 postoperative hours
7. Time to mobilization in the ICU in hours.
8. Postoperative complications
9. Fluid use
10. Blood product use
11. Intensive care unit (ICU) and hospital length of stay (LOS)
12. Readmissions within 30 postoperative days
13. In-hospital and 30-day mortality
Intervention code [1] 325087 0
Not applicable
Comparator / control treatment
Patients who underwent primary coronary artery bypass grafting (CABG) surgery via midline sternotomy and received usual care.

Usual care will include patients who did not receive methadone or a protocolized fast-track cardiac anaesthesia protocol.
Control group
Active

Outcomes
Primary outcome [1] 333393 0
Total mechanical ventilation time in hours adjusted for the hospital, body mass index, category of surgical urgency, cardiopulmonary bypass (CPB), and European System for Cardiac Operative Risk Evaluation (EuroSCORE II). This will be collected from the electronic medical records
Timepoint [1] 333393 0
Total mechanical ventilation time will be calculated from completion of surgery to tracheal extubation in the intensive care unit.
Secondary outcome [1] 416887 0
The number of patients who have a successful tracheal extubation within four postoperative hours. This will be collected from the electronic medical records
Timepoint [1] 416887 0
Timing will commence on completion of surgery to 4 postoperative hours.
Secondary outcome [2] 416888 0
Total cumulative intravenous (IV) opioid requirements within the first 24 and 48 postoperative hours measured in in milligrams. This will be collected from the electronic medical records
Timepoint [2] 416888 0
Intravenous morphine equivalent daily dose in milligrams on postoperative on the first 24 and 48 postoperative hours. Morphine equivalent will be calculated using the Opioid Dose Equivalence document endorsed by the Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists.
Secondary outcome [3] 416889 0
Postoperative pain scores at rest and during movement will be independently assessed in the post-anaesthetic care unit (PACU). These data will be collected from the electronic medical records. The Pain score will be quantified using the Numerical Pain Rating Scale (NRS) for pain. The Numerical Rating Scale (NRS) is an 11-point numerical scale that defines a respondent’s severity of perceived pain between no pain designated a score of 0 and the worst possible pain designated a score of 10.
Timepoint [3] 416889 0
This will be measured on Postoperative days 0-2. Every pain score that is documented in the medical record will be collected.
Secondary outcome [4] 416890 0
Postoperative opioid-related adverse events collected from the electronic medical records. These events include respiratory depression, nausea and vomiting and sedation scores.
Timepoint [4] 416890 0
This will be determined by the period from completion of surgery to hospital discharge.
Secondary outcome [5] 416891 0
Complications will be defined as any deviation from the normal postoperative course, guided by the European Perioperative Clinical Outcome definitions. Complications will be recorded by two independent clinicians, and then graded using Clavien-Dindo Classification - a widely used and validated approach to surgical outcome assessment that assigns severity grades to surgical complications. These data will be collected from the electronic medical records.
Timepoint [5] 416891 0
Complications will be determined by the period from completion of surgery to hospital discharge.
Secondary outcome [6] 416892 0
Length of hospital stay (LOS) will be collected from the patient's hospital electronic medical record.
Timepoint [6] 416892 0
LOS will be determined by the period from completion of surgery to discharge.
Secondary outcome [7] 417516 0
Duration of anaesthesia in minutes. This will be collected from the patient's hospital electronic medical record.
Timepoint [7] 417516 0
This is the time period under anaesthesia measured from induction of anaesthesia to completion of surgery.
Secondary outcome [8] 417517 0
Duration of cardiopulmonary bypass. This will be collected from the patient's hospital electronic medical record.
Timepoint [8] 417517 0
This is the time period during surgery from when the patient commences cardiopulmonary bypass from cardiopulmonary bypass .
Secondary outcome [9] 417518 0
Time to mobilisation in the ICU in hours. This will be collected from the patient's hospital electronic medical record.
Timepoint [9] 417518 0
This will be measured in hours, commencing from when the patient is admitted into ICU to when the patient first mobilises i.e., walks or sits in a chair.
Secondary outcome [10] 417519 0
Intravenous fluid use. This will be collected from the patient's hospital electronic medical record.
Timepoint [10] 417519 0
This will be measured over the first 48 hours post surgery.
Secondary outcome [11] 417520 0
Blood product use. This will be collected from the patient's hospital electronic medical record.
Timepoint [11] 417520 0
This will be measured over the first 48 hours post surgery.
Secondary outcome [12] 417521 0
ICU length of stay. This will be collected from the patient's hospital electronic medical record.
Timepoint [12] 417521 0
This will be measured in hours, commencing from when the patient is admitted into ICU to when the patient first mobilises i.e., walks or sits in a chair.
Secondary outcome [13] 417522 0
Readmissions within 30 post-operative days. This will be collected from the electronic medical records.
Timepoint [13] 417522 0
Postoperative days 0-30; up to 1 month after surgery.
Secondary outcome [14] 417523 0
In-hospital mortality. This will be collected from the patient's hospital electronic medical record.
Timepoint [14] 417523 0
Postoperative days; up until hospital discharge.
Secondary outcome [15] 417524 0
30-day mortality. This will be collected from the patient's hospital electronic medical record.
Timepoint [15] 417524 0
Postoperative days; up until 30 days post hospital discharge.

Eligibility
Key inclusion criteria
Patients who undergo primary CABG surgery via midline sternotomy will be screened between February 2019 and February 2022.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patients will be excluded:

1. Time-critical salvage CABG (e.g., patients admitted with out-of-hospital arrest in cardiogenic shock requiring emergency CABG)
2. Patients undergoing CABG combined with valve surgery
3. Patients undergoing CABG combined with surgery on the aorta,
4. Patients undergoing redo surgeries
5. Patients with a preoperative cardiac assist device in situ
6. Patients undergoing CABG after 6 p.m. as these patients often remained on mechanical ventilation support until the next postoperative morning

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using R 4.2.0 (R Development Core Team, Vienna, Austria, 2022) and associated packages. Normality will be tested by graphical methods using a quantile-quantile plot for continuous variables. The patient characteristics and postoperative outcome associations between Fast-track and Usual care groups will be investigated using the Wilcoxon-Mann-Whitney test for continuous variables and Fisher’s exact or chi-squared test for categorical variables.

Violin plots will be constructed to compare the data distribution of the unadjusted values of total mechanical ventilation time between the groups. The Wilcoxon-Mann-Whitney test will be used to test for statistical significance between the two violin plots. To investigate the adjusted difference in ventilation time between the fast track and usual care groups, a linear regression model will be built. We will only examine the estimated difference in total ventilation hours among patients who received postoperative sedation and ventilator care and exclude those that are extubated on the table. As the dependent variable, we will use the logarithm of the total mechanical ventilation time in hours. Allocation to either the Fast-track or the Usual care group will be used as an independent variable. Body mass index, category of surgery, whether the surgery was performed in a public or private hospital, CPB time, and EuroSCORE II will be chosen as "a priori" selected covariates.

A modified survival plot will be created to model “time-to-event,” where time will be recorded in hours and the event will be defined as tracheal extubation. The Kaplan-Meier model will be used to compare the differences between the fast-track and usual care groups. The log-rank test will be used to calculate the statistical significance between the two groups in the survival plot.

Box plots will be used to compare the secondary outcomes of total equivalent IV morphine use in milligrams between the groups in the 0–24-hour and 24–48-hour periods. The Wilcoxon-Mann-Whitney test will be used to calculate the statistical significance between the Fast-track and Usual care groups during these periods. Data will be expressed as the median (1st:3rd quartile) or number (percentile). All the calculated p-values will be two-sided. Statistical significance will be set at a p-value of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
Actual
9/09/2022
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
187
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23732 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 23733 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 39173 0
3084 - Heidelberg
Recruitment postcode(s) [2] 39174 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 312867 0
Hospital
Name [1] 312867 0
Austin Health - Austin Hospital - Heidelberg
Country [1] 312867 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Austin Hospital - Heidelberg
Address
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 314529 0
None
Name [1] 314529 0
Address [1] 314529 0
Country [1] 314529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312144 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 312144 0
Ethics committee country [1] 312144 0
Australia
Date submitted for ethics approval [1] 312144 0
24/02/2022
Approval date [1] 312144 0
24/03/2022
Ethics approval number [1] 312144 0
HREC/22?Austin/38

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123638 0
Prof Laurence Weinberg
Address 123638 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 123638 0
Australia
Phone 123638 0
+61394965249
Fax 123638 0
+61394966421
Email 123638 0
[email protected]
Contact person for public queries
Name 123639 0
Laurence Weinberg
Address 123639 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 123639 0
Australia
Phone 123639 0
+61394965249
Fax 123639 0
+61394966421
Email 123639 0
[email protected]
Contact person for scientific queries
Name 123640 0
Laurence Weinberg
Address 123640 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 123640 0
Australia
Phone 123640 0
+61394965249
Fax 123640 0
+61394966421
Email 123640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17882Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.