Respiratory Distress Syndrome, Adult
Conditions
Keywords
Positive-Pressure Respiration, Respiration, Artificial
Brief summary
Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.
Detailed description
In patients with Acute Respiratory Distress Syndrome the use of Positive End-Expiratory Pressure (PEEP) avoids atelectrauma, improves gas exchange and induces alveolar recruitment.Although it has side effects as inducing alveolar overdistension and circulatory depression. There are several methods to determine the level of PEEP to be applied. We conducted a study to test the hypothesis that an individualized level of PEEP, set et the best compliance, when compared with a fixed level according to the fraction of inspired oxygen applied, improves oxygenation and reduces mortality rate at 28 days.
Interventions
All patients were ventilated during 24 hours with low tidal volume (6-8 milliliters/kilogram of predicted body weight), plateau airway pressure limited at 35 centimeters of water, initial ventilator rate of 30 breaths/minute adjusted to maintain a pH goal of 7.30 to 7.45 to a maximum of 35 breaths/minute, fraction of inspired oxygen ensuring arterial oxygen saturation 88-95% or arterial partial pressure of oxygen of 55-80 mmHg. Level of Positive End-Expiratory Pressure (PEEP) applied according the 2 arms of treatment.
Sponsors
Hospital Universitario Principe de Asturias
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
* Patients with Acute Respiratory Distress Syndrome (ARDS) according to the American-European Consensus Conference definition, after 24 hours under mechanical ventilation.
Exclusion criteria
* Younger than 18-year-old * Pregnancy * Neuromuscular diseases * Intracranial hypertension. Head trauma * Left ventricular dysfunction * Mechanical ventilation for more than 72 hours * Previous barotrauma * Patients with terminal stage of an illness and high risk of mortality within 90 days * Patients who refused to consent to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Oxygenation | 28 days | Evolution of arterial oxygenation during the 28 days after study randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28 days | Mortality 28 days after randomization |
| Number of ventilator-free days at day 28 | 28 days | Number of ventilator-free days at day 28 after randomization |
| multivariate analysis of mortality | 28 days | — |
Countries
Spain
Outcome results
None listed