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ART-2 Pilot - Driving Pressure Limited Ventilation for Patients With ARDS

ART-2 Pilot: A Controlled, Randomized Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs. Standard Strategy (ARDSNet) in Patients With ARDS

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02365038
Acronym
ART2pilot
Enrollment
20
Registered
2015-02-18
Start date
2015-06-12
Completion date
2017-07-01
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Brief summary

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).

Detailed description

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.

Interventions

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.

Sponsors

Hospital do Coracao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients on invasive mechanical ventilation with diagnosis of ARDS of less than 72 hours duration.

Exclusion criteria

* Less than 18 years old. * Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (\<7 days) acute coronary syndrome. * Patients in which a high probability of death within 24 hours is anticipated. * Patients under exclusive palliative care.

Design outcomes

Primary

MeasureTime frameDescription
Mean driving pressure between day 1 and day 3Day 1 to Day 3 after randomizationDriving 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.

Secondary

MeasureTime frame
Length of stay in intensive care unitICU stay
Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control groupDays 1 to 7
Rate of driving pressure equal or lower than 13cmH2ODays 1 to 3 after randomization
Mean PEEP from day 1 to 7Days 1 to 7
Mean tidal volume from day 1 to day 7Days 1 to 7
Mean static compliance of the respiratory system from day 1 to day 7Days 1 to 7
Mean plateau pressure from day 1 to day 7Days 1 to 7
Mean driving pressure from day 1 to day 7Days 1 to 7
Mean respiratory rate from day 1 to day 7Days 1 to 7
BarotraumaDays 1 to 7
Severe acidosis (pH <7.1)Days 1 to 7
Other adverse eventsDays 1 to 7
Length of stay in hospitalIn-hospital stay
Mechanical ventilation free days from day 0 to day 28From day 0 to day 28
ICU mortalityICU stay
In-hospital mortalityHospital stay
28-day survivalFrom day 0 to day 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026