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

Acute Respiratory Distress Syndrome Clinical Trial

— ART2pilot  

Official title:

ART-2 Pilot: A Controlled, Randomized Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs. Standard Strategy (ARDSNet) in Patients With ARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365038
• Other study ID #: ART2pilot
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 12, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2015
• 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 the ARDS Clinical Network strategy (conventional strategy) in patients with 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 with acute respiratory distress syndrome (ARDS). Thus, ART2pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with ARDS. Patients considered to this trial are those in mechanical ventilation with diagnosis of ARDS of less than 72 hours duration. 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 ARDSNet strategy. The primary outcome is driving pressure between days 1 and 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2017
• Est. primary completion date: February 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

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
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Driving pressure limited ventilation
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.
• Conventional ventilation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to study procedures: daily adjustement of driving pressure in experimental group and tidal volume in the control group		Days 1 to 7
Secondary	Rate of driving pressure equal or lower than 13cmH2O		Days 1 to 3 after randomization
Secondary	Mean PEEP from day 1 to 7		Days 1 to 7
Secondary	Mean tidal volume from day 1 to day 7		Days 1 to 7
Secondary	Mean static compliance of the respiratory system from day 1 to day 7		Days 1 to 7
Secondary	Mean plateau pressure from day 1 to day 7		Days 1 to 7
Secondary	Mean driving pressure from day 1 to day 7		Days 1 to 7
Secondary	Mean respiratory rate from day 1 to day 7		Days 1 to 7
Secondary	Barotrauma		Days 1 to 7
Secondary	Severe acidosis (pH <7.1)		Days 1 to 7
Secondary	Other adverse events		Days 1 to 7
Secondary	Length of stay in intensive care unit		ICU stay
Secondary	Length of stay in hospital		In-hospital stay
Secondary	Mechanical ventilation free days from day 0 to day 28		From day 0 to day 28
Secondary	ICU mortality		ICU stay
Secondary	In-hospital mortality		Hospital stay
Secondary	28-day survival		From day 0 to day 28