Clinical trial NCT01119872: Pilot Study of Positive-End Expiratory Pressure in Acute Respiratory Distress Syndrome
Official title: Randomized Controlled Pilot Study of Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome(ARDS): Individualized According to the Best Compliance or Fixed According to Fraction of Inspired Oxygen (FiO2) Applied
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Keywords: Positive-Pressure Respiration
Respiration, Artificial
Lead sponsor: Hospital Universitario Principe de Asturias
Sponsor class: OTHER
First posted: 2010-05-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arterial Oxygenation
timeFrame: 28 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Number of ventilator-free days at day 28
timeFrame: 28 days
measure: multivariate analysis of mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Critical Care Unit. Universitary Hospital Principe de Asturias
state: Madrid
Study officials:
affiliation: Critical Care Unit. Universitary Hospital Principe de Asturias
name: María del Consuelo Pintado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Critical Care Unit. Universitary Hospital Principe de Asturias
name: Raúl de Pablo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
citation: Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62. doi: 10.1378/chest.73.2.158.
citation: Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.