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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01667146
Registration number
NCT01667146
Ethics application status
Date submitted
12/08/2012
Date registered
17/08/2012
Date last updated
28/11/2018
Titles & IDs
Public title
A Multi-centre Trial of an Open Lung Strategy Including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in Patients With Acute Respiratory Distress Syndrome
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Scientific title
A Multi-centre Randomised Controlled Trial of an Open Lung Strategy Including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in Patients With Acute Respiratory Distress Syndrome.
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Secondary ID [1]
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ANZIC-RC/AD002 Version 8
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Universal Trial Number (UTN)
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Trial acronym
PHARLAP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Distress Syndrome
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
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Complications of newborn
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Injuries and Accidents
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Other injuries and accidents
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - PHARLAP mechanical ventilation strategy
Other interventions - Control group mechanical ventilation strategy
Experimental: PHARLAP ventilation group - PHARLAP mechanical ventilation strategy
Active Comparator: Control group ventilation - Control group mechanical ventilation strategy
Other interventions: PHARLAP mechanical ventilation strategy
Pressure control ventilation to maintain tidal volume 4-6 ml/kg and plateau pressure = 30 cmH2O while tolerating respiratory acidosis if pH > 7.15; daily staircase recruitment manoeuvre and individualised PEEP titration.
Other interventions: Control group mechanical ventilation strategy
Mechanical ventilation based on the ARDSnet protocol using volume control ventilation with tidal volume 6 ml/kg, plateau pressure = 30 cmH2O and FiO2/PEEP titration according to a FiO2/PEEP/oxygen saturation combination chart. This has been modified for Australian and New Zealand practice to allow pressure control and pressure support ventilation.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of ventilator free days at day 28 post randomisation
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Assessment method [1]
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Timepoint [1]
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28 days post randomisation
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Secondary outcome [1]
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PaO2/FiO2 ratio and static lung compliance
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Assessment method [1]
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Timepoint [1]
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Up to day 28 post randomisation
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Secondary outcome [2]
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Baseline to day 3 change in IL-8 and IL-6 concentrations in broncho-alveolar lavage and plasma
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Assessment method [2]
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Timepoint [2]
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Day 3 post randomisation
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Secondary outcome [3]
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Incidence of severe hypotension
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Assessment method [3]
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Timepoint [3]
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Up to 90 days post randomisation
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Secondary outcome [4]
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Incidence of barotrauma
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Assessment method [4]
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Timepoint [4]
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Up to 90 days post randomisation
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Secondary outcome [5]
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Use of rescue therapies for severe hypoxaemia - inhaled nitric oxide, inhaled prostacyclin, prone positioning, high frequency oscillatory ventilation and extracorporeal membrane oxygenation (ECMO)
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Assessment method [5]
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Timepoint [5]
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Within hospital admission
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Secondary outcome [6]
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Mortality
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Assessment method [6]
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At timepoints: ICU discharge, hospital discharge, 28 days, 90 days and 6 months
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Timepoint [6]
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Up to 6 months post randomisation
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Secondary outcome [7]
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ICU and hospital length of stay
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Assessment method [7]
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Timepoint [7]
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Up to 6 months
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Secondary outcome [8]
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Incidence of AKI
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Assessment method [8]
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Timepoint [8]
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Within hospital admission
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Secondary outcome [9]
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Quality of life assessment
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Assessment method [9]
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SF36v2
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Timepoint [9]
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6 months post randomisation
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Secondary outcome [10]
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Cost effectiveness analysis
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Assessment method [10]
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Based on EQ-5D
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Timepoint [10]
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6 months post randomisation
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Eligibility
Key inclusion criteria
Adult ICU patients who met all of the following criteria:
- Currently intubated and receiving mechanical ventilation
- Within 72 Hours of a diagnosis of ARDS (moderate and severe) based on the following
Berlin definition:
- Within 1 week of a known clinical insult or new or worsening respiratory symptoms
- Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung
collapse or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
- PaO2/FiO2 < 200mmHg with PEEP = 5cmH2O
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- > 72 hours since diagnosis of ARDS
- > 10 days of continuous mechanical ventilation
- Barotrauma (pneumothorax, pneumomediastinum, subcutaneous emphysema or any intercostal
catheter for the treatment of air leak)
- Significant chest trauma i.e. multiple rib fractures
- Active bronchospasm or a history of significant chronic obstructive pulmonary disease
or asthma
- Clinical suspicion for significant restrictive lung disease (history of pulmonary
fibrosis or suggestive pulmonary function tests)
- Moderate or severe traumatic brain injury, the presence of an intracranial pressure
monitor, or any medical condition associated with a clinical suspicion of raised
intracranial pressure
- Unstable cardiovascular status defined as sustained heart rate < 40 or > 140 bpm,
ventricular tachycardia, or SBP < 80mmHg
- Pregnancy
- Receiving ECMO
- Receiving high frequency oscillatory ventilation
- Death is deemed imminent and inevitable
- The treating physician believes it is not in the best interest of the patient to be
enrolled in the trial
- Consent not obtained or refused by patient's legal surrogate
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2018
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Sample size
Target
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Accrual to date
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Final
115
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Albury/Wodonga - Albury
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Recruitment hospital [3]
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Royal Prince Alfred - Sydney
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Recruitment hospital [4]
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Wollongong Hospital - Wollongong
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Recruitment hospital [5]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [6]
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Flinders Medical Centre - Adelaide
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Recruitment hospital [7]
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Geelong Hospital - Geelong
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Recruitment hospital [8]
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The Alfred Hosptial - Melbourne
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Recruitment postcode(s) [1]
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- Albury
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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- Sydney
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment postcode(s) [5]
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- Brisbane
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Recruitment postcode(s) [6]
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- Adelaide
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Recruitment postcode(s) [7]
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3220 - Geelong
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Ireland
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State/province [1]
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Dublin
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Country [2]
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Ireland
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State/province [2]
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Limerick
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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Saudi Arabia
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State/province [4]
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Riyadh
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Country [5]
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United Kingdom
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State/province [5]
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Cambridgeshire
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Country [6]
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United Kingdom
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State/province [6]
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Devon
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Country [7]
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United Kingdom
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State/province [7]
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Kent
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Country [8]
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United Kingdom
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State/province [8]
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Surrey
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Country [9]
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United Kingdom
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State/province [9]
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Bristol
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Country [10]
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United Kingdom
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State/province [10]
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Hull
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Country [11]
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United Kingdom
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State/province [11]
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London
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Country [12]
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United Kingdom
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State/province [12]
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Middlesbrough
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Some people develop the condition called acute respiratory distress syndrome (ARDS). This is
a condition where the lungs have become injured from one of a number of various causes, and
do not work as they normally do to provide oxygen and remove carbon dioxide from the body.
This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS
are admitted to the intensive care unit (ICU) and need help with their breathing by being
connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of the
body causing other problems but also death.
Over the past few years, reducing the size of each breath delivered by the ventilator in
conjunction with the use of an occasional sustained deep breath called a "recruitment
manoeuvre" have been used to try to prevent further damage to the lungs in people with ARDS.
This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research
study to have some beneficial effects without causing any obvious harm, when compared to a
current best practice ventilator strategy. The main beneficial effects of the PHARLAP
strategy were to increase the amount of oxygen in the blood and to reduce markers of
inflammation (the body reacting to a disease process) in the body. This study was too small
to make a strong conclusion, so this study will be much larger and will assess whether
patients who have developed ARDS are better off when we use the PHARLAP strategy. Three
hundred and forty patients will be enrolled into this study in multiple ICUs across Australia
and New Zealand.
The study hypothesis is that the PHARLAP strategy group will have a higher number of
ventilator free days at day 28 than the control group.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01667146
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carol Hodgson, PhD, FACP, BAppSc (Physio)
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Address
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Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01667146
Download to PDF