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NCT Number: NCT02365038

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Driving pressure limited ventilation

Other

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.

Conventional ventilation

Other

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.

Other names: ARDSNet strategy

Primary outcomes

  1. Mean driving pressure between day 1 and day 3

    Time frame: Day 1 to Day 3 after randomization

    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.

Secondary outcomes

  1. 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

  2. Rate of driving pressure equal or lower than 13cmH2O

    Time frame: Days 1 to 3 after randomization

  3. Mean PEEP from day 1 to 7

    Time frame: Days 1 to 7

  4. Mean tidal volume from day 1 to day 7

    Time frame: Days 1 to 7

  5. Mean static compliance of the respiratory system from day 1 to day 7

    Time frame: Days 1 to 7

  6. Mean plateau pressure from day 1 to day 7

    Time frame: Days 1 to 7

  7. Mean driving pressure from day 1 to day 7

    Time frame: Days 1 to 7

  8. Mean respiratory rate from day 1 to day 7

    Time frame: Days 1 to 7

  9. Barotrauma

    Time frame: Days 1 to 7

  10. Severe acidosis (pH <7.1)

    Time frame: Days 1 to 7

  11. Other adverse events

    Time frame: Days 1 to 7

  12. Length of stay in intensive care unit

    Time frame: ICU stay

  13. Length of stay in hospital

    Time frame: In-hospital stay

  14. Mechanical ventilation free days from day 0 to day 28

    Time frame: From day 0 to day 28

  15. ICU mortality

    Time frame: ICU stay

  16. In-hospital mortality

    Time frame: Hospital stay

  17. 28-day survival

    Time frame: From day 0 to day 28

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Registry information

Official study title

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

Acronym: ART2pilot

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2015
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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