A Phase 1/2 interventional study of Driving pressure limited ventilation and Conventional ventilation in Acute Respiratory Distress Syndrome, sponsored by Hospital do Coracao. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Hospital do Coracao · Phase 1/2, Interventional, and Treatment
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS).
Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients with acute respiratory distress syndrome (ARDS). Thus, ART2pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with ARDS. Patients considered to this trial are those in mechanical ventilation with diagnosis of ARDS of less than 72 hours duration. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or ARDSNet strategy. The primary outcome is driving pressure between days 1 and 3.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Hospital do Coracao is the lead sponsor of 66 studies on the registry; 14 are open to participants now.
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Exclusion criteria:
Driving pressure limited ventilation
Other: Driving pressure limited ventilation
Mechanical ventilation as proposed in the ARDSNet protocol.
Other: Conventional ventilation
We will use volume controlled ventilation or pressure support in the weaning phase. We will adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). We will not limit plateau pressure in this arm.
ARDSNet Strategy: conventional mechanical ventilation strategy with tidal volume between 4 and 6 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.
Also known as: ARDSNet strategy
Mean driving pressure between day 1 and day 3
Driving pressure is the difference between plateau pressure and PEEP. It will be measured every morning in patients without spontaneous efforts. As every patients will have up to three measurements, we will consider the mean driving pressure for each patient.
Time frame: Day 1 to Day 3 after randomization
Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group
Time frame: Days 1 to 7
Rate of driving pressure equal or lower than 13cmH2O
Time frame: Days 1 to 3 after randomization
Mean PEEP from day 1 to 7
Time frame: Days 1 to 7
Mean tidal volume from day 1 to day 7
Time frame: Days 1 to 7
Mean static compliance of the respiratory system from day 1 to day 7
Time frame: Days 1 to 7
Mean plateau pressure from day 1 to day 7
Time frame: Days 1 to 7
Mean driving pressure from day 1 to day 7
Time frame: Days 1 to 7
Mean respiratory rate from day 1 to day 7
Time frame: Days 1 to 7
Barotrauma
Time frame: Days 1 to 7
Severe acidosis (pH <7.1)
Time frame: Days 1 to 7
Other adverse events
Time frame: Days 1 to 7
Length of stay in intensive care unit
Time frame: ICU stay
Length of stay in hospital
Time frame: In-hospital stay
Mechanical ventilation free days from day 0 to day 28
Time frame: From day 0 to day 28
ICU mortality
Time frame: ICU stay
In-hospital mortality
Time frame: Hospital stay
28-day survival
Time frame: From day 0 to day 28
No study locations are listed for this record.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Hospital do Coracao