FindTrial
Sign In

ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01374022
Acronym
ART
Enrollment
1013
Registered
2011-06-15
Start date
2011-06-30
Completion date
2017-12-31
Last updated
2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Respiratory Distress Syndrome, Adult, Randomized Controlled Trial, Respiration, Artificial

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.

Interventions

OTHERART Strategy

Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.

OTHERARDSNet Strategy

Conventional mechanical ventilation strategy.

Sponsors

Hospital do Coracao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival in 28 days28 daysSurvival within 28 days from randomization

Secondary

MeasureTime frameDescription
Lenght of hospital stayMaximum 6 monthsLength of hospital stay from randomization to hospital discharge
Lenght of ICU stayMaximum 6-monthsLength of hospital stay from randomization to ICU discharge
Pneumothorax requiring drainage7 daysWe 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.
Barotrauma7 daysWe 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.
Days free of mechanical ventilation28 daysNumber of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
ICU survivalMaximum 6-monthsSurvival at ICU discharge.
In-hospital survivalMaximum 6-monthsSurvival at hospital discharge.
6-month survival6 monthsSurvival within 6 months after randomization

Other

MeasureTime frameDescription
Severe acidosis (pH < 7.10) in the first hour1 hourSevere acidosis (pH \< 7.10) in the first hour after randomization
Cardiorespiratory arrest within 24 hours24 hoursCardiorespiratory arrest defined as unexpected cardiac arrest, not due to progressive refractory shock within 24 hours after randomization.
Deaths with refractory hypoxemia within 7 days7 daysDeath with refractory hypoxemia, defined as PaO2 \< 55 mmHg in the last arterial blood gas analysis with FiO2 = 100%.
Death with refractory acidosis within 7 days7 daysDeath with refractory acidosis within 7 days, defined as pH ≤ 7.10 in the last arterial blood gas analysis
Death with barotrauma within 7 days7 daysDeath with barotrauma within 7 days after randomization. We consider as barotrauma any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams, except those judged to be clearly caused by invasive procedures.
Hypoxemia (PaO2 < 55mmHg) in the first hour1 hourHypoxemia (PaO2 \< 55mmHg) in the first hour after randomization
Need of commencement/increase of vasopressors or hypotension (MAP < 65mmHg) in the first hour;1 hourNeed of commencement/increase of vasopressors or hypotension (MAP \< 65mmHg) in the first hour after randomization.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026