PHARLAP, protocol version 8uk
Research type
Research Study
Full title
A multi-centre randomized controlled trial of an Open lung Strategy including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in patients with acute respiratory distress syndrome
IRAS ID
187443
Contact name
Phil Hopkins
Contact email
Sponsor organisation
Monash University Department of Epidemiology and Preventive Medicine
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A clinical trial to determine if a mechanical ventilation strategy for the treatment of acute respiratory distress syndrome (ARDS) decreases the number of days a patient receives mechanical ventilation.
ARDS 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, New Zealand, Saudi Arabia and Europe.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
15/YH/0559
Date of REC Opinion
18 Jan 2016
REC opinion
Further Information Favourable Opinion