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

Acute Respiratory Distress Syndrome Clinical Trial

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.

Status Terminated

Clinical Trial 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 Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acute Lung Injury
Acute Respiratory Distress Syndrome
Hypercapnia
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome

Clinical Trial Details

NCT number	NCT01667146
Study type	Interventional
Source	Australian and New Zealand Intensive Care Research Centre
Contact
Status	Terminated
Phase	N/A
Start date	October 2012
Completion date	March 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04384445` - Zofin (Organicell Flow) for Patients With COVID-19	Phase 1/Phase 2
Recruiting	`NCT05535543` - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed	`NCT04695392` - Restore Resilience in Critically Ill Children	N/A
Terminated	`NCT04972318` - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia	N/A
Completed	`NCT04534569` - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Completed	`NCT04078984` - Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
Completed	`NCT04451291` - Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure	N/A
Not yet recruiting	`NCT06254313` - The Role of Cxcr4Hi neutrOPhils in InflueNza
Not yet recruiting	`NCT04798716` - The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19	Phase 1/Phase 2
Withdrawn	`NCT04909879` - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome	Phase 2
Not yet recruiting	`NCT02881385` - Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation	N/A
Terminated	`NCT02867228` - Noninvasive Estimation of Work of Breathing	N/A
Completed	`NCT02545621` - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Withdrawn	`NCT02253667` - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients	N/A
Completed	`NCT02232841` - Electrical Impedance Imaging of Patients on Mechanical Ventilation	N/A
Completed	`NCT01504893` - Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia	N/A
Completed	`NCT02889770` - Dead Space Monitoring With Volumetric Capnography in ARDS Patients	N/A
Withdrawn	`NCT01927237` - Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide	N/A
Completed	`NCT02814994` - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients	N/A
Completed	`NCT01680783` - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.