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

Not Applicable

Withdrawn

• Conditions: Mechanical Ventilation; Acute Respiratory Distress Syndrome
• Interventions: Other: Conventional ventilation; Other: Driving pressure limited ventilation

• Registration Number: NCT02376647
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Study Start: 2022-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ventilation	Conventional ventilation	Mechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O)
Driving pressure limited ventilation	Driving pressure limited ventilation	Driving pressure limited ventilation (≤13cmH2O)

Primary Outcome Measures

Name	Time	Method
Mean driving pressure between Day 1 and Day 3	From Day 1 to Day 3 after randomization

Secondary Outcome Measures

Name	Time	Method
Rate of driving pressure equal or lower than 13 cmH2O	Days 1 to 3 after randomization
Mean tidal volume from day 1 to 7	Days 1 to 7
Mean plateau pressure from day 1 to 7	Days 1 to 7
Mean of severe acidosis (pH <7.1)	Days 1 to 7
Rate of investigators adering to study procedures	Days 1 to 7
Mean of positive end expiratory pressure (PEEP) from day 1 to 7	Days 1 to 7
Lenght of stay in hospital	Patients will be followed during the period of hospital stay, an expected average of 28 days
Number of patients with barotrauma	Days 1 to 7
Number of mechanical ventilation free days from day 0 to day 28	From day 0 to day 28
28-day survival	From day 0 to day 28
Mean static compliance of the respiratory system 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 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
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

Trial Locations

Locations (1)

Alexandre Biasi Cavalcanti; 🇧🇷 São Paulo, SP, Brazil