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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

Information source: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Respiratory Distress Syndrome

Intervention: PHARLAP mechanical ventilation strategy (Other); Control group mechanical ventilation strategy (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Australian and New Zealand Intensive Care Research Centre

Official(s) and/or principal investigator(s):
Carol Hodgson, PhD, FACP, BAppSc (Physio), Study Chair, Affiliation: Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)
Alistair Nichol, PhD, FCICM, Study Chair, Affiliation: Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)

Overall contact:
Victoria L Bennett, Phone: +61 399030280, Email: victoria.bennett@monash.edu

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.

Clinical Details

Official 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of ventilator free days at day 28 post randomisation

Secondary outcome:

PaO2/FiO2 ratio and static lung compliance

Baseline to day 3 change in IL-8 and IL-6 concentrations in broncho-alveolar lavage and plasma

Incidence of severe hypotension

Incidence of barotrauma

Use of rescue therapies for severe hypoxaemia - inhaled nitric oxide, inhaled prostacyclin, prone positioning, high frequency oscillatory ventilation and extracorporeal membrane oxygenation (ECMO)

Mortality

ICU and hospital length of stay

Incidence of AKI

Quality of life assessment

Cost effectiveness analysis

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Adult ICU patients who met all of the following criteria:

- Currently intubated and receiving mechanical ventilation

- Within 48 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

Exclusion Criteria:

- > 48 hours since diagnosis of ARDS

- > 5 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

- 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

- Has received a staircase recruitment manoeuvre for this episode of ARDS

- 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

Locations and Contacts

Victoria L Bennett, Phone: +61 399030280, Email: victoria.bennett@monash.edu

St Vincents Hospital, Dublin, Ireland; Recruiting
Alistair Nichol

Auckland City Hospital (DCCM), Auckland 1142, New Zealand; Recruiting
Colin McArthur

Auckland City Hospital CVICU, Auckland 1142, New Zealand; Recruiting
Shay McGuinness

Wellington Hospital, Wellington 6242, New Zealand; Recruiting
Paul Young

King Abdulaziz Medical City, Riyadh, Saudi Arabia; Recruiting
Yaseen Arabi

Middlemore Hospital, Otahuhu, Auckland 1640, New Zealand; Recruiting
Anthony Williams

Nepean Hospital, Kingswood, New South Wales 2747, Australia; Recruiting
Ian Seppelt

John Hunter Hospital, New Lambton, New South Wales 2306, Australia; Recruiting
Peter Harrigan

Royal North Shore, Sydney, New South Wales 2065, Australia; Recruiting
Lewis Macken

Royal Prince Alfred, Sydney, New South Wales, Australia; Recruiting
Richard Totaro

Wollongong Hospital, Wollongong, New South Wales 2500, Australia; Recruiting
Alan Davey-Quinn

The Prince Charles Hospital, Brisbane, Queensland, Australia; Recruiting
John Fraser

Flinders Medical Centre, Adelaide, South Australia, Australia; Recruiting
Andrew Bersten

Lyell McEwin Hospital, Elizabeth Vale, South Australia 5112, Australia; Recruiting
Peter Thomas

Launceston, Launceston, Tasmania, Australia; Recruiting
Matthew Brain

Albury/Wodonga, Albury, Victoria, Australia; Recruiting
David Tuxen

The Northern Hospital, Epping, Victoria 3076, Australia; Recruiting
Angaj Ghosh

Geelong Hospital, Geelong, Victoria 3220, Australia; Recruiting
Neil Orford

Austin Health, Heidelberg, Victoria 3132, Australia; Recruiting
Rinaldo Bellomo

The Alfred Hosptial, Melbourne, Victoria 3004, Australia; Recruiting
David Tuxen, Principal Investigator

Additional Information

Starting date: October 2012
Last updated: January 13, 2015

Page last updated: August 23, 2015

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