ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Maximum Alveolar Recruitment Maneuver Plus Titrated PEEP Versus ARDSNet Strategy for ARDS

Conditions
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Respiratory Distress Syndrome, Adult

Intervention / Treatment
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* Other: ART Strategy
* Other: ARDSNet Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ART Strategy<br>maximum alveolar recruitment plus PEEP titration | Other: ART Strategy<br>* Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.<br>|
| Active Comparator: ARDSNet Strategy<br>standard strategy (ARDSNet) | Other: ARDSNet Strategy<br>* Conventional mechanical ventilation strategy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in 28 days | Survival within 28 days from randomization | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lenght of ICU stay | Length of hospital stay from randomization to ICU discharge | Maximum 6-months | 
| Lenght of hospital stay | Length of hospital stay from randomization to hospital discharge | Maximum 6 months | 
| Pneumothorax requiring drainage | 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. | 7 days | 
| Barotrauma | 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. | 7 days | 
| Days free of mechanical ventilation | Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization. | 28 days | 
| ICU survival | Survival at ICU discharge. | Maximum 6-months | 
| In-hospital survival | Survival at hospital discharge. | Maximum 6-months | 
| 6-month survival | Survival within 6 months after randomization | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Distress Syndrome, Adult, Randomized Controlled Trial, Respiration, Artificial