Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000974202
Ethics application status
Approved
Date submitted
16/06/2009
Date registered
11/11/2009
Date last updated
25/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lung recruitment maneuvers for acute lung collapse in ventilated patients.
Scientific title
The efficacy of lung recruitment manoeuvres versus standard care in resolving acute lung collapse on chest x-ray in ventilated patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lung collapse 236906 0
Condition category
Condition code
Respiratory 237260 237260 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the treatment group will be positioned in side lying with the affected side uppermost and ventilated in pressure controlled mode with a pressure control level of 15 cmH2O (up to 18) and will receive a step-wise recruitment treatment protocol where positive end expiratory pressure (PEEP) is increased incrementally from 10 (or other baseline) to 20, 30cm H20 every 2 minutes and then decreased to PEEP of 15cmH2O. This will be maintained for the remainder of the day with one short re-recruitment maneuver (to max pressure 40cmH2O for 2 minutes). 4 hours prior to reassessment the patient will be returned to pre-existing ventilatory settings and previous PEEP levels. Patients will receive an staircase recruitment manoeuver (SRM) every day for the duration of mechanical ventilation.
Intervention code [1] 236695 0
Treatment: Other
Comparator / control treatment
Standard treatment (patient will be positioned side lying with the collapsed lung uppermost. Physiotherapists will apply ventilator hyperinlfation which is large tidal volume breaths with peak inspiratory pressure < 40cmH20 for 10 minutes).
Control group
Active

Outcomes
Primary outcome [1] 238073 0
Chest-x-ray score
Timepoint [1] 238073 0
24 hours following randomisation
Primary outcome [2] 238074 0
partial pressure of oxygen in the blood as measured by blood gas analysis divided by the fraction of inspired oxygen (PaO2/FiO2)
Timepoint [2] 238074 0
24 hours following randomisation
Primary outcome [3] 238075 0
Static lung compliance measured by automatic flow interruption technique
Timepoint [3] 238075 0
24 hours following randomisation
Secondary outcome [1] 242266 0
Ventilator associated pneumonia diagnosed using assessment of symptoms, x-ray and sputum analysis
Timepoint [1] 242266 0
During intubation assessed daily

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion is they are mechanically ventilated, have an arterial line for blood gas analyses and blood pressure monitoring, a central venous catheter and are diagnosed with chest x-ray collapse/atelectasis on the morning of data collection by the intensive care unit (ICU) consultant or senior registrar on call. No new lines will be placed for study inclusion.
Minimum age
16 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have an ICC (intercostals catheter) in situ with current or previous air leak, a pneumothorax on chest x-ray, acute respiratory distress syndrome (ARDS) , acute bronchospasm, raised intracranial pressure, acute pulmonary oedema or haemodynamic instability (mean arterial pressure<60 mmHg, arrhythmias).

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)
Screened daily by research nurses for acute lung collapse if ventilated.
If fits inclusion criteria and not exclusion criteria patient will be allocated randomly by computer generated sequence by blinded person to study and sealed in opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence by blinded person to study.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237165 0
Hospital
Name [1] 237165 0
Alfred Hospital
Country [1] 237165 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Commercial Rd Prahran
VICTORIA 3181
Country
Australia
Secondary sponsor category [1] 4654 0
University
Name [1] 4654 0
Monash
Address [1] 4654 0
Peninsula Campus PO Box 527 Frankston, Victoria, 3199
Country [1] 4654 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239257 0
Alfred Hospital
Ethics committee address [1] 239257 0
Commercial Rd Prahran
VICTORIA 3181
Ethics committee country [1] 239257 0
Australia
Date submitted for ethics approval [1] 239257 0
15/06/2009
Approval date [1] 239257 0
14/07/2009
Ethics approval number [1] 239257 0
1/09/0176

Summary
Brief summary
To determine if recruitment manoeuvres are more effective than standard care in resolving acute lung collapse on chest x-ray.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29686 0
Address 29686 0
Country 29686 0
Phone 29686 0
Fax 29686 0
Email 29686 0
Contact person for public queries
Name 12933 0
Carol Hodgson
Address 12933 0
Physiotherapy Department
Alfred Hospital
Commercial Rd Prahran
VICTORIA 3181
Country 12933 0
Australia
Phone 12933 0
61 3 9076 3452
Fax 12933 0
61 3 9076 2702
Email 12933 0
c.hodgson@alfred.org.au
Contact person for scientific queries
Name 3861 0
Carol Hodgson
Address 3861 0
Physiotheapy Department
Alfred Hospital
Commercial Rd Prahran
VICTORIA 3181
Country 3861 0
Australia
Phone 3861 0
61 3 9076 3452
Fax 3861 0
61 3 9076 2702
Email 3861 0
c.hodgson@alfred.org.au

No information has been provided regarding IPD availability


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
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