ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Other: ARDSNet Strategy; Other: ART Strategy

• Registration Number: NCT01374022
• Lead Sponsor: Hospital do Coracao

Brief Summary

Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Mechanical ventilation is recognized to play an important role in treatment of patients with ARDS. However, mechanical ventilation itself has the potential to produce or worsen alveolar injury if inadequate strategies are chosen. Several studies compared different mechanical ventilation strategies in ARDS but the results remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a multicentric randomized controlled trial, with allocation concealment and intention to treat analysis to investigate if maximum alveolar recruitment maneuver in association to Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART strategy) is able to increase 28 days survival in patients with moderate to severe ARDS compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients considered to this trial are those in mechanical ventilation with diagnosis of moderate to severe ARDS less than 72hours. Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1013

Inclusion Criteria

• intubated, mechanically ventilated patients with diagnosis of moderate to severe ARDS less than 72 hours

Exclusion Criteria

• age less than 18 years
• use of vasopressor drugs in increasing doses over the last 2 hours or mean arterial blood pressure less than 65mmHg
• presence of any contraindication to hypercapnia as intracranial hypertension or acute coronary syndrome
• pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele
• patient with no therapeutic perspective, candidates for palliative care exclusively
• patient previously randomized in the ART

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARDSNet Strategy	ARDSNet Strategy	standard strategy (ARDSNet)
ART Strategy	ART Strategy	maximum alveolar recruitment plus PEEP titration

Primary Outcome Measures

Name	Time	Method
Survival in 28 days	28 days	Survival within 28 days from randomization

Secondary Outcome Measures

Name	Time	Method
In-hospital survival	Maximum 6-months	Survival at hospital discharge.
Days free of mechanical ventilation	28 days	Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
ICU survival	Maximum 6-months	Survival at ICU discharge.
Pneumothorax requiring drainage	7 days	We consider as pneumothorax requiring chest tube within 7 days any case that is possibly due to barotrauma, that is, we do not consider cases judged to be clearly caused by invasive procedures such as central venous punction or thoracocentesis.
Lenght of ICU stay	Maximum 6-months	Length of hospital stay from randomization to ICU discharge
Barotrauma	7 days	We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures.
6-month survival	6 months	Survival within 6 months after randomization
Lenght of hospital stay	Maximum 6 months	Length of hospital stay from randomization to hospital discharge

Trial Locations

Locations (1)

Hospital do Coracao; 🇧🇷 Sao Paulo, SP, Brazil