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Completed

NCT Number: NCT01119872

Pilot Study of Positive-End Expiratory Pressure in Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Respiratory Distress Syndrome, Adult Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Critical Care Unit. Universitary Hospital Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive End-expiratory Pressure (PEEP)

Other

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.

Other names: Compliance-guided PEEP group: Grupo meseta, FiO2-driven-PEEP group: Grupo tabla

Primary outcomes

  1. Arterial Oxygenation

    Time frame: 28 days

    Evolution of arterial oxygenation during the 28 days after study randomization

Secondary outcomes

  1. Mortality

    Time frame: 28 days

    Mortality 28 days after randomization

  2. Number of ventilator-free days at day 28

    Time frame: 28 days

    Number of ventilator-free days at day 28 after randomization

  3. multivariate analysis of mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Hospital Universitario Principe de Asturias

Other

Registry information

Official study 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

Acronym: PEEP-HUPA

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
May 10, 2010
Registry last updated
May 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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