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

NCT ID: NCT02376647

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-10-31

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.

Conditions

Mechanical Ventilation; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Driving pressure limited ventilation

Driving pressure limited ventilation (≤13cmH2O)

Group Type: EXPERIMENTAL

Driving pressure limited ventilation

Intervention Type: OTHER

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.

Conventional ventilation

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

Group Type: ACTIVE_COMPARATOR

Conventional ventilation

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brazilian Research in Intensive Care Network (BRICNet)

UNKNOWN

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre B Cavalcanti, MD, PhD

Role: STUDY_CHAIR

Hospital do Coração(Heart Hospital)

Locations

Alexandre Biasi Cavalcanti

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ART-3pilot

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ART-3pilot

Identifier Type: -

Identifier Source: org_study_id