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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

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).

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Acute Respiratory Distress Syndrome Other: Driving pressure limited ventilation Other: Conventional ventilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ART-3 Pilot: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy in Patients Without ARDS
Study Start Date : March 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: Driving pressure limited ventilation
Driving pressure limited ventilation (≤13cmH2O)
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.


Active Comparator: Conventional ventilation
Mechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O)
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).




Primary Outcome Measures :
  1. Mean driving pressure between Day 1 and Day 3 [ Time Frame: From Day 1 to Day 3 after randomization ]

Secondary Outcome Measures :
  1. Rate of investigators adering to study procedures [ Time Frame: Days 1 to 7 ]
  2. Rate of driving pressure equal or lower than 13 cmH2O [ Time Frame: Days 1 to 3 after randomization ]
  3. Mean of positive end expiratory pressure (PEEP) from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  4. Mean tidal volume from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  5. Mean static compliance of the respiratory system from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  6. Mean plateau pressure from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  7. Mean driving pressure from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  8. Mean respiratory rate from day 1 to 7 [ Time Frame: Days 1 to 7 ]
  9. Number of patients with barotrauma [ Time Frame: Days 1 to 7 ]
  10. Mean of severe acidosis (pH <7.1) [ Time Frame: Days 1 to 7 ]
  11. Number of patients with other adverse events [ Time Frame: Days 1 to 7 ]
  12. 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 ]
  13. Lenght of stay in hospital [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  14. Number of mechanical ventilation free days from day 0 to day 28 [ Time Frame: From day 0 to day 28 ]
  15. ICU mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  16. In-hospital mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  17. 28-day survival [ Time Frame: From day 0 to day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376647


Contacts
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Contact: Alexandre B Cavalcanti, MD, PhD + 55 11 30536611 ext 8102 abiasi@hcor.com.br
Contact: Lígia N Laranjeira 55 11 3053-6611 ext 8210 lnasi@hcor.com.br

Sponsors and Collaborators
Hospital do Coracao
Brazilian Research in Intensive Care Network (BRICNet)
Investigators
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Study Chair: Alexandre B Cavalcanti, MD, PhD Hospital do Coração(Heart Hospital)
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT02376647    
Other Study ID Numbers: ART-3pilot
ART-3pilot ( Other Grant/Funding Number: Hospital do Coração )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Keywords provided by Hospital do Coracao:
Patients
ARDS diagnosis
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury