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

ART-3 Pilot: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy in Patients Without ARDS

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).

Study Overview

• Status: Withdrawn
• Conditions: Acute Respiratory Distress Syndrome; Mechanical Ventilation
• Intervention / Treatment: Other: Driving pressure limited ventilation; Other: Conventional ventilation

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04005000
      • Alexandre Biasi Cavalcanti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean driving pressure between Day 1 and Day 3	From Day 1 to Day 3 after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU mortality	Patients will be followed during the period of hospital stay, an expected average of 28 days
In-hospital mortality	Patients will be followed during the period of hospital stay, an expected average of 28 days
28-day survival	From day 0 to day 28
Rate of investigators adering to study procedures	Days 1 to 7
Rate of driving pressure equal or lower than 13 cmH2O	Days 1 to 3 after randomization
Mean of positive end expiratory pressure (PEEP) from day 1 to 7	Days 1 to 7
Mean tidal volume from day 1 to 7	Days 1 to 7
Mean static compliance of the respiratory system from day 1 to 7	Days 1 to 7
Mean plateau pressure from day 1 to 7	Days 1 to 7
Mean driving pressure from day 1 to 7	Days 1 to 7
Mean respiratory rate from day 1 to 7	Days 1 to 7
Number of patients with barotrauma	Days 1 to 7
Mean of severe acidosis (pH <7.1)	Days 1 to 7
Number of patients with other adverse events	Days 1 to 7
Lenght of stay in intensive care unit	Patients will be followed during the period of ICU stay, an expected average of 28 days
Lenght of stay in hospital	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	From day 0 to day 28

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Brazilian Research in Intensive Care Network (BRICNet)
• Investigators: Study Chair: Alexandre B Cavalcanti, MD, PhD, Hospital do Coração(Heart Hospital)

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Patients; ARDS diagnosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ART-3pilot (Other Grant/Funding Number: Hospital do Coração)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No