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

Acute Respiratory Distress Syndrome Clinical Trial

— ART-3pilot  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02376647
• Other study ID #: ART-3pilot
• Secondary ID: ART-3pilot
• Status: Withdrawn
• Phase: N/A
• Start date: March 2022
• Est. completion date: October 2024

Study information

• Verified date: September 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Mechanical Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.
• 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).

Locations

Country	Name	City	State
Brazil	Alexandre Biasi Cavalcanti	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Brazilian Research in Intensive Care Network (BRICNet)

Country where clinical trial is conducted

Brazil, 

Outcome

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