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 (PHARLAP)
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|ClinicalTrials.gov Identifier: NCT01667146|
Recruitment Status : Terminated (Halted by the Management Committee after the publication of the ART Trial)
First Posted : August 17, 2012
Last Update Posted : November 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Other: PHARLAP mechanical ventilation strategy Other: Control group mechanical ventilation strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2012|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||March 2018|
Experimental: PHARLAP ventilation group
PHARLAP mechanical ventilation strategy
Other: 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.
Active Comparator: Control group ventilation
Control group mechanical ventilation strategy
Other: 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.
- Number of ventilator free days at day 28 post randomisation [ Time Frame: 28 days post randomisation ]
- PaO2/FiO2 ratio and static lung compliance [ Time Frame: Up to day 28 post randomisation ]
- Baseline to day 3 change in IL-8 and IL-6 concentrations in broncho-alveolar lavage and plasma [ Time Frame: Day 3 post randomisation ]
- Incidence of severe hypotension [ Time Frame: Up to 90 days post randomisation ]
- Incidence of barotrauma [ Time Frame: Up to 90 days post randomisation ]
- Use of rescue therapies for severe hypoxaemia - inhaled nitric oxide, inhaled prostacyclin, prone positioning, high frequency oscillatory ventilation and extracorporeal membrane oxygenation (ECMO) [ Time Frame: Within hospital admission ]
- Mortality [ Time Frame: Up to 6 months post randomisation ]At timepoints: ICU discharge, hospital discharge, 28 days, 90 days and 6 months
- ICU and hospital length of stay [ Time Frame: Up to 6 months ]
- Incidence of AKI [ Time Frame: Within hospital admission ]
- Quality of life assessment [ Time Frame: 6 months post randomisation ]SF36v2
- Cost effectiveness analysis [ Time Frame: 6 months post randomisation ]Based on EQ-5D
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667146
|Study Chair:||Carol Hodgson, PhD, FACP, BAppSc (Physio)||Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)|
|Study Chair:||Alistair Nichol, PhD, FCICM||Australian and New Zealand Intensive Care Research Centre (ANZIC-RC)|