Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000268549
Ethics application status
Approved
Date submitted
5/06/2006
Date registered
29/06/2006
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Date results provided
28/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The cardiac and respiratory response to recruitment maneuvers (RM) in ventilated patients with acute lung injury.
Scientific title
The cardiac and respiratory response to a stepwise recruitment maneuver in ventilated patients with acute lung injury.
Secondary ID [1] 313261 0
doi: 10.1177/0885066610383953
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lung injury 1244 0
Acute respiratory distress syndrome (ARDS) 1245 0
Condition category
Condition code
Respiratory 1329 1329 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recruitment maneuver(RM) - before and after. The RM is a stepwise increase in positive end exiratory pressure (PEEP) level from baseline to 40cm H20, with 2 minutes at each PEEP level and then reduced slowly to optimal PEEP (as determined by the SaO2)The RM will last for 10 minutes with no control. Measurement will be made before and after the one intervention (RM) in all subjects.
Intervention code [1] 1124 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1815 0
Shunt Fraction and SaO2
Timepoint [1] 1815 0
Before and after a recruitment maneuver
Primary outcome [2] 1816 0
Venous oxygen levels
Timepoint [2] 1816 0
Before and after a recruitment maneuver
Secondary outcome [1] 3181 0
Cardiac function including cardiac output, blood pressure and respiratory function.
Timepoint [1] 3181 0
Static lung compliance at 2 minute intervals throughout the intervention and at 30 and 60 minutes after the intervention.

Eligibility
Key inclusion criteria
Ventilated, with ALI/ARDS.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ICC with air leak, pneumothorax, asthma, unstable haemodynamics eg. MAP < 60 mmHg.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
17/03/2007
Date of last participant enrolment
Anticipated
Actual
24/09/2008
Date of last data collection
Anticipated
Actual
30/09/2008
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1456 0
University
Name [1] 1456 0
Monash University
Country [1] 1456 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 1285 0
Hospital
Name [1] 1285 0
Alfred Hospital
Address [1] 1285 0
Alfred Hospital, Commercial Rd Prahran, 3181
Country [1] 1285 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2833 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 2833 0
Ethics committee country [1] 2833 0
Australia
Date submitted for ethics approval [1] 2833 0
20/04/2006
Approval date [1] 2833 0
31/07/2006
Ethics approval number [1] 2833 0
138/06
Ethics committee name [2] 2834 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 2834 0
Ethics committee country [2] 2834 0
Australia
Date submitted for ethics approval [2] 2834 0
Approval date [2] 2834 0
31/07/2006
Ethics approval number [2] 2834 0
138/06

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

Contacts
Principal investigator
Name 36034 0
Carol Hodgson
Address 36034 0
553 St Kilda Road, Melbourne, 3004
Country 36034 0
Australia
Phone 36034 0
+61 48674532
Fax 36034 0
Email 36034 0
[email protected]
Contact person for public queries
Name 10313 0
Carol Hodsgon
Address 10313 0
Physiotherapy Department
Alfred Hospital
Prahran VIC 3181
Country 10313 0
Australia
Phone 10313 0
+61 3 92763450
Fax 10313 0
+61 3 92762702
Email 10313 0
[email protected]
Contact person for scientific queries
Name 1241 0
Associate Professor David Tuxen
Address 1241 0
Intenisve Care Department
Alfred Hospital
Prahran VIC 3181
Country 1241 0
Australia
Phone 1241 0
+61 3 92762000
Fax 1241 0
Email 1241 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.