Pilot Study of Positive-End Expiratory Pressure in Acute Respiratory Distress Syndrome (PEEP-HUPA)

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier:
NCT01119872
First received: May 6, 2010
Last updated: May 7, 2010
Last verified: December 2002
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome, Adult
Other: Positive End-expiratory Pressure (PEEP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Principe de Asturias:

Primary Outcome Measures:
  • Arterial Oxygenation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Evolution of arterial oxygenation during the 28 days after study randomization


Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Mortality 28 days after randomization

  • Number of ventilator-free days at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Number of ventilator-free days at day 28 after randomization

  • multivariate analysis of mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Compliance-guided PEEP group
Positive End-Expiratory Pressure(PEEP) level was set daily, according to the method described by Suter in 1978. Static compliance (Cst) was calculated at different levels of PEEP at a constant tidal ventilation of 6-8 ml/kg of predicted body weight. Cst was determined by dividing tidal volume by the difference between the pressure at the end of inflation hold and the PEEP. The maximum value of Cst in individual patients was considered as the best PEEP.
Other: Positive End-expiratory Pressure (PEEP)

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
FiO2-driven-PEEP group
PEEP was set based on the patient fraction of inspired oxygen (FiO2) according to the Positive End-Expiratory Pressure(PEEP) strategy reported in 2000:"Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network".
Other: Positive End-expiratory Pressure (PEEP)

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119872

Locations
Spain
Critical Care Unit. Universitary Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Sponsors and Collaborators
Hospital Universitario Principe de Asturias
Investigators
Principal Investigator: María del Consuelo Pintado, MD, PhD Critical Care Unit. Universitary Hospital Principe de Asturias
Principal Investigator: Raúl de Pablo, MD, PhD Critical Care Unit. Universitary Hospital Principe de Asturias
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: María del Consuelo Pintado, Critical Care Unit. Universitary Hospital Príncipe de Asturias
ClinicalTrials.gov Identifier: NCT01119872     History of Changes
Other Study ID Numbers: UCI-HUPA-1
Study First Received: May 6, 2010
Last Updated: May 7, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario Principe de Asturias:
Positive-Pressure Respiration
Respiration, Artificial

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014