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

NCT02365038 | Completed Phase 1

• 1 other identifier: ART2pilot
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to Day 3 after randomization

Secondary Outcomes (17)

• Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group

  Days 1 to 7

• Rate of driving pressure equal or lower than 13cmH2O

  Days 1 to 3 after randomization

• Mean PEEP from day 1 to 7

  Days 1 to 7

• Mean tidal volume from day 1 to day 7

  Days 1 to 7

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

  Days 1 to 7

Study Arms (2)

Driving pressure limited ventilation

EXPERIMENTAL

Driving pressure limited ventilation

Other: Driving pressure limited ventilation

Conventional ventilation

ACTIVE COMPARATOR

Mechanical ventilation as proposed in the ARDSNet protocol.

Other: Conventional ventilation

Interventions

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.

Driving pressure limited ventilation

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.

Also known as: ARDSNet strategy

Conventional ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Related Publications (1)

• Pereira Romano ML, Maia IS, Laranjeira LN, Damiani LP, Paisani DM, Borges MC, Dantas BG, Caser EB, Victorino JA, Filho WO, Amato MBP, Cavalcanti AB. Driving Pressure-limited Strategy for Patients with Acute Respiratory Distress Syndrome. A Pilot Randomized Clinical Trial. Ann Am Thorac Soc. 2020 May;17(5):596-604. doi: 10.1513/AnnalsATS.201907-506OC.

  PMID: 32069068 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Alexandre B Cavalcanti, MD, PhD

  Hospital do Coracao (Heart Hospital)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 18, 2015
• Study Start: June 12, 2015
• Primary Completion: February 25, 2017
• Study Completion: July 1, 2017
• Last Updated: July 28, 2021

Record last verified: 2015-02