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ART-3 Pilot - Driving Pressure Limited Ventilation for Patients Without ARDS (ART3pilot) (ART-3pilot)

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ClinicalTrials.gov Identifier: NCT02376647
Recruitment Status : Unknown
Verified February 2015 by Hospital do Coracao.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2015
Last Update Posted : March 4, 2015
Sponsor:
Collaborator:
Brazilian Research in Intensive Care Network (BRICNet)
Information provided by (Responsible Party):
Hospital do Coracao

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date March 4, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Mean driving pressure between Day 1 and Day 3 [ Time Frame: From Day 1 to Day 3 after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Rate of investigators adering to study procedures [ Time Frame: Days 1 to 7 ]
  • Rate of driving pressure equal or lower than 13 cmH2O [ Time Frame: Days 1 to 3 after randomization ]
  • Mean of positive end expiratory pressure (PEEP) from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  • Mean tidal volume from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  • Mean static compliance of the respiratory system from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  • Mean plateau pressure from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  • Mean driving pressure from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  • Mean respiratory rate from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  • Number of patients with barotrauma [ Time Frame: Days 1 to 7 ]
  • Mean of severe acidosis (pH <7.1) [ Time Frame: Days 1 to 7 ]
  • Number of patients with other adverse events [ Time Frame: Days 1 to 7 ]
  • Lenght of stay in intensive care unit [ Time Frame: Patients will be followed during the period of ICU stay, an expected average of 28 days ]
  • Lenght of stay in hospital [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  • Number of mechanical ventilation free days from day 0 to day 28 [ Time Frame: From day 0 to day 28 ]
  • ICU mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  • In-hospital mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  • 28-day survival [ Time Frame: From day 0 to day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ART-3 Pilot - Driving Pressure Limited Ventilation for Patients Without ARDS (ART3pilot)
Official Title  ICMJE ART-3 Pilot: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy in Patients Without ARDS
Brief Summary This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without 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 without acute respiratory distress syndrome (ARDS).

Thus, ART-3 pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without ARDS. Patients considered to this trial are those in mechanical ventilation for less than 72 hours without diagnosis of ARDS. 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 conventional strategy (tidal volume of 8 mL/kg of predicted body weight). The primary outcome is driving pressure between days 1 and 3.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mechanical Ventilation
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Other: Driving pressure limited ventilation

    Investigators will use volume controlled (or pressure support ventilation) and 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). Investigators will not limit plateau pressure in this arm.

    Once a daily the investigators will assess the target tidal volume that generates a driving pressure of 13cmH2O. The patient should be sedated and without spontaneous efforts during this assessment.

  • Other: Conventional ventilation
    Investigators will use volume controlled or pressure support ventilation, tidal volume ≤8 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 35 breathings per minute).
Study Arms  ICMJE
  • Experimental: Driving pressure limited ventilation
    Driving pressure limited ventilation (≤13cmH2O)
    Intervention: Other: Driving pressure limited ventilation
  • Active Comparator: Conventional ventilation
    Mechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O)
    Intervention: Other: Conventional ventilation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients on invasive mechanical ventilation for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02376647
Other Study ID Numbers  ICMJE ART-3pilot
ART-3pilot ( Other Grant/Funding Number: Hospital do Coração )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital do Coracao
Study Sponsor  ICMJE Hospital do Coracao
Collaborators  ICMJE Brazilian Research in Intensive Care Network (BRICNet)
Investigators  ICMJE
Study Chair: Alexandre B Cavalcanti, MD, PhD Hospital do Coração(Heart Hospital)
PRS Account Hospital do Coracao
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP