Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000133932p
Ethics application status
Submitted, not yet approved
Date submitted
13/01/2020
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of different ventilation strategies on patient outcomes post-cardiopulmonary bypass
Scientific title
Effect of different ventilation strategies on the proportion of patients requiring non-invasive ventilation post-cardiopulmonary bypass
Secondary ID [1] 300250 0
None
Universal Trial Number (UTN)
U1111-1246-4034
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Mechanical ventilation 315810 0
Cardiac surgery 315811 0
Condition category
Condition code
Anaesthesiology 314101 314101 0 0
Other anaesthesiology
Respiratory 314221 314221 0 0
Other respiratory disorders / diseases
Cardiovascular 314222 314222 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivered tidal volumes of 6ml/kg of ideal body weight versus 10ml/kg of ideal body weight in mechanically ventilated patients post-cardiopulmonary bypass.
- Ventilation between CPB and admission to ICU will be outside of the study's remit and delivered by GE ventilator in theatre.
- Mechanical ventilation for the purpose of the study will begin when the patient is admitted to ICU. Tidal volumes, as per randomisation, will be delivered until the patient is extubated or up to 90 days.
- Mechanical ventilator used on ICU for the study: Maquet Servo-i ventilator
- NIV used in ICU for the study: Maquet Servo-i ventilator
- Fidelity to the intervention is assessed depending on the system operated on for the patient. 1) a linked in computerised system that slaves real-time data about ventilator settings, volumes, pressures and other vital monitoring. 2) paper notes taken by nurses on standard ICU flow charts. Both of these systems will be interrogated for each patient by the investigators to ensure study protocols were adhered to at all times
Intervention code [1] 316521 0
Prevention
Comparator / control treatment
Delivered tidal volumes of 6ml/kg of ideal body weight
Control group
Active

Outcomes
Primary outcome [1] 322490 0
The proportion of patients requiring non-invasive ventilation.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [1] 322490 0
Within the first five days post-cardiopulmonary bypass (CPB) or until hospital discharge, re-intubation or death
Secondary outcome [1] 378681 0
The proportion of patients requiring high-flow nasal prongs (HFNP).
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [1] 378681 0
within the first five days post-CPB or until hospital discharge, re-intubation or death.
Secondary outcome [2] 378682 0
The duration of intubation, measured in minutes.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [2] 378682 0
from when the patient was admitted to the Intensive Care Unit (ICU) until they were extubated or died, to a maximum of 90 days.
Secondary outcome [3] 378683 0
The proportion of patient’s that required re-intubation after being extubated post-admission to the ICU.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [3] 378683 0
Up to 90 days
Secondary outcome [4] 378684 0
The duration of the patient’s stay on the ICU post-CPB, measured in minutes.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [4] 378684 0
Up to 90 days
Secondary outcome [5] 378685 0
The duration of the patient’s stay in hospital post-CPB, in days.
Information regarding the management of a patient outside of ICU is documented by nursing and medical staff on a compterised documentation system. Information about the length of hospital stay will be retrieved by the investigators who will then fill out the relevant information on the Case Report Form
Timepoint [5] 378685 0
until they were discharged home, spent up to 180 days in hospital, or died.
Secondary outcome [6] 378686 0
The amount of intravenous fluids, measured in litres, infused post-CPB.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [6] 378686 0
in the first 24 hours post-admission to the ICU
Secondary outcome [7] 378687 0
The amount of intravenous blood products, measured in units, infused post-CPB.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [7] 378687 0
in the first 24 hours post–admission to the ICU.
Secondary outcome [8] 378688 0
The proportion of patients requiring noradrenaline above 0.15mcg/kg/min.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [8] 378688 0
during the period of intubation post-CPB from when the patient was admitted to the Intensive Care Unit (ICU) until they were extubated or died, to a maximum of 90 days..
Secondary outcome [9] 378689 0
The proportion of patients requiring dobutamine above 5mcg/kg/min.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation
Timepoint [9] 378689 0
during the period of intubation post-CPB from when the patient was admitted to the Intensive Care Unit (ICU) until they were extubated or died, to a maximum of 90 days..
Secondary outcome [10] 378690 0
The development of new Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS – as per the Berlin criteria).
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation.
Calculation regarding diagnosis can be conducted by the nursing team, medical staff or investigators
Timepoint [10] 378690 0
during the time of intubation post-admission to the ICU after CPB
Secondary outcome [11] 378691 0
The development of new pneumonia, which requires the initiation of antimicrobial therapy.
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation.
Timepoint [11] 378691 0
during the time of intubation post-admission to the ICU after CPB
Secondary outcome [12] 378692 0
The development of acute renal failure stage 2 (as per the KDIGO guidelines).
Medical and nursing staff of the ICU will be educated about the study and a Case Report Form that will be attached to the patient's notes. The team will be required to fill out the CRF for each patient.
Information regarding the management of a patient is also documented by nursing and medical staff on a compterised documentation system and paper notes. Any missing information on the CRF can be completed by the investigators by analysing these forms of documentation.
Timepoint [12] 378692 0
during the time of intubation post-admission to the ICU after CPB

Eligibility
Key inclusion criteria
- Male or female
- 18 to 85 years old
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any patient that did not undergo cardiopulmonary bypass
- Patients undergoing a salvage operation
- Pre-operative intra-aortic balloon pump
- Pre-operative ECMO

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer and sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 200 patients (n = 100 per arm) will be included in this study. One-way ANOVA testing will be used for continuous variables whilst chi-square testing will be used for categorical variables. Demographic data will be presented with summary statistics (number of participants, mean, standard deviation, median and range). Post-hoc comparisons will be performed using the Tukey post-hoc test. Univariate regression analysis is to be performed before analysing appropriately significant variables (P<0.1) with multivariate regression analysis. A subgroup analysis will be performed excluding patients who had ECMO or an IABP whilst a pre-defined sensitivity analysis will also be performed for those who were operated on as an emergency, have pre-defined obstructive respiratory disease or a BMI >30

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/04/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2021
Actual
Date of last data collection
Anticipated
2/07/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15613 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 29013 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 304675 0
Hospital
Name [1] 304675 0
Prince of Wales Hospital
Country [1] 304675 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Barker Street,
Randwick,
2031, NSW
Country
Australia
Secondary sponsor category [1] 304983 0
None
Name [1] 304983 0
Address [1] 304983 0
Country [1] 304983 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305096 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305096 0
Ethics committee country [1] 305096 0
Australia
Date submitted for ethics approval [1] 305096 0
31/01/2020
Approval date [1] 305096 0
Ethics approval number [1] 305096 0

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

Contacts
Principal investigator
Name 99258 0
Dr Mohamed Kamal
Address 99258 0
Prince of Wales Hospital
Intensive Care Unit
Barker Street
Randwick, 2031, NSW
Country 99258 0
Australia
Phone 99258 0
+61434134500
Fax 99258 0
Email 99258 0
[email protected]
Contact person for public queries
Name 99259 0
Mohamed Kamal
Address 99259 0
Prince of Wales Hospital
Intensive Care Unit
Barker Street
Randwick, 2031, NSW
Country 99259 0
Australia
Phone 99259 0
+61434134500
Fax 99259 0
Email 99259 0
[email protected]
Contact person for scientific queries
Name 99260 0
Mohamed Kamal
Address 99260 0
Prince of Wales Hospital
Intensive Care Unit
Barker Street
Randwick, 2031, NSW
Country 99260 0
Australia
Phone 99260 0
+61434134500
Fax 99260 0
Email 99260 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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.