The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000403831
Ethics application status
Approved
Date submitted
19/03/2012
Date registered
10/04/2012
Date last updated
19/05/2020
Date data sharing statement initially provided
19/05/2020
Date results information initially provided
19/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of protective intra-operative ventilation with alveolar recruitment strategies in minimising acute lung injury in lung transplantation.
Scientific title
A randomised controlled trial in adult lung transplantation patients comparing low tidal volume and PEEP versus pressure controlled ventilation, recruitment manoeuvres and PEEP, in order to establish whether one technique is more beneficial at preventing acute lung injury.
Secondary ID [1] 280118 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung transplantation 286039 0
respiratory 317525 0
Condition category
Condition code
Anaesthesiology 286230 286230 0 0
Anaesthetics
Respiratory 286464 286464 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pressure-controlled ventilation 16cmH2O, repeated recruitment manoeuvres, positive end-expiratory pressure 10cmH2O with a tidal volume limit of 10ml/kg for two-lung ventilation and 6ml/kg for one-lung ventilation. The respiratory rate will be titrated to control partial pressures of carbon dioxide, from allograft insertion to end of surgery
Intervention code [1] 284452 0
Treatment: Surgery
Intervention code [2] 317625 0
Treatment: Other
Comparator / control treatment
Low tidal volume ventilation (6ml/kg for two-lung ventilation, 4ml/kg for one-lung ventilation) / positive end-expiratory pressure 5mmHg. The respiratory rate will be titrated to control partial pressures of carbon dioxide, from allograft insertion to end of surgery.
Control group
Active

Outcomes
Primary outcome [1] 286707 0
Partial pressure of oxygen (PaO2): Fraction of inspired oxygen (FiO2) ratio - indicating incidence and severity of acute lung injury. Completed by blood gass, and documentation of the FiO2 at the relevant timepoints.
Timepoint [1] 286707 0
0, 1, 2, 6 and 12 hours post surgical completion of lung transplant.
Secondary outcome [1] 296498 0
Pulmonary graft dysfunction grade based on PaO2:FiO2 ratio and chest x-rays
Timepoint [1] 296498 0
Blood gas results at 0, 1, 2, 6 and 12 hours post surgical completion of lung transplant. Chest x-ray at 24hours post lung transplant.
Secondary outcome [2] 296499 0
Pulmonary vascular resistance levels using echocardiographic measurements of right ventricular systolic function
Timepoint [2] 296499 0
Baseline in transplant recipient, 5 minutes after pulmonary artery clamping, as the sternal wires are secured at the conclusion of the surgical procedure.
Secondary outcome [3] 296500 0
Inflammatory markers assessed via venous blood samples and bronchoalveolar lavage.
Timepoint [3] 296500 0
Blood samples - in donor lungs prior to surgical procedure, at the conclusion of the surgical procedure, and 3,6, and 12hrs post surgical procedure.
Bronchoalveolar lavage - 24hrs post surgical procedure
Secondary outcome [4] 296501 0
Time to tracheal extubation
Timepoint [4] 296501 0
From time of intubation until extubation post surgery.
Secondary outcome [5] 296502 0
Intensive care unit length of stay
Timepoint [5] 296502 0
From admission to intensive care unit post surgical procedure until discharge to the ward.
Secondary outcome [6] 296503 0
Hospital length of stay
Timepoint [6] 296503 0
From admission to the intensive care unit, until discharge from the ward to rehabilitation or home.
Secondary outcome [7] 296504 0
Incidence of extracorporeal membrane oxygenation
Timepoint [7] 296504 0
Requirement within first 24 hours post surgical completion and length of time required.

Eligibility
Key inclusion criteria
Patient presenting for bilateral sequential lung transplantation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Single lung transplantation or combined heart-lung procedure.
Planned use of cardiopulmonary bypass - severe pulmonary hypertension (mean pulmoary artery pressure > 60 mmHg) or significant right ventricular dysfunction.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be approached in the pre assesment Transplant clinic by the Respiratory Physicians. Consent will be obtained pre operatively.
Allocation of treatment will be radomally allocated to one of two treatment via computer generated random lists. After consent each patient will be given a treatment number which will correlate to a number on an opaque sealed enevelope. Inside will be the treatment code, following this the document will be signed and returned to a second opaque envelope for storage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients to be randomised on a 1:1 basis using a computer-generated list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16710 0
The Alfred - Prahran
Recruitment postcode(s) [1] 30310 0
3004 - Prahran
Recruitment postcode(s) [2] 30311 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 284881 0
Self funded/Unfunded
Name [1] 284881 0
Address [1] 284881 0
Country [1] 284881 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
The Alfred Hospital,
Commercial Rd,
Prahran, VIC, 3181
Country
Australia
Secondary sponsor category [1] 283926 0
University
Name [1] 283926 0
Monash
Address [1] 283926 0
Monash University
Wellington Road
Clayton
Victoria 3800
Country [1] 283926 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286874 0
Alfred Health research and ethics committee
Ethics committee address [1] 286874 0
Alfred Health
Commercial road
Melbourne
Vic 3004
Ethics committee country [1] 286874 0
Australia
Date submitted for ethics approval [1] 286874 0
19/03/2012
Approval date [1] 286874 0
19/03/2012
Ethics approval number [1] 286874 0

Summary
Brief summary
Single-centre, randomised-controlled trial with a comparison of two protective ventilation techniques in order to determine the effect on the incidence of acute lung injury/ischaemia-reperfusion injury.

Primary aims:
1. To determine the incidence and severity of acute lung injury post lung transplantation.
2. To determine the incidence of inflammatory markers in serum and bronchoalveolar lavage samples during anf after lung transplantation
3. To analyse the association between inflammatory markers and acute lung injury
4. To determine whether there is a decrease in the level of inflammation and incidence of acute lung injury associated with pressure-controlled, high positive end-expiratory pressure and alveolar recruitment

Secondary aims:
1. To determine whether further protective ventilation techniques should be incorporated into lung transplantation anaesthesia.

Hypothesis:
Pressure-controlled ventilation and high positive end-expiratory pressure with the addition of alveolar recruitment will be more beneficial in minimising acute lung injury than low tidal volume protective ventilation alone in lung transplantation after allograft insertion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33903 0
Prof Paul Myles
Address 33903 0
Department of Anaesthesiology and Perioperative Mediicne
Alfred Hospital
55 commercial road
Melbourne, 3181
Victoria
Country 33903 0
Australia
Phone 33903 0
+61390762651
Fax 33903 0
Email 33903 0
p.myles@alfred.org.au
Contact person for public queries
Name 17150 0
Prof Genna Verbeek
Address 17150 0
Department of Anaesthesia and Perioperative Medicine,
The Alfred hospital,
PO Box 315,
Prahran, VIC, 3181
Country 17150 0
Australia
Phone 17150 0
+61 3 9076 2651
Fax 17150 0
Email 17150 0
glver2@student.monash.edu.au
Contact person for scientific queries
Name 8078 0
Prof Professor Paul Myles
Address 8078 0
Department of Anaesthesia and Perioperative Medicine,
The Alfred hospital,
PO Box 315,
Prahran, VIC, 3181
Country 8078 0
Australia
Phone 8078 0
+61 3 9076 3176
Fax 8078 0
Email 8078 0
p.myles@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not required at time of ethics approval. requests will be considered
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 8000 0
Verbeek GL, Myles PS, Westall GP, Lin E, Hastings S, Marasco S, Jaffa J, Meehan A. Intra-operative protective mechanical ventilation in lung transplantation: A randomised controlled trial. Anaesthesia 2017
Attachments [1] 8000 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary