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

Respiratory Distress Syndrome, Adult Clinical Trial

— PEEP-HUPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119872
• Other study ID #: UCI-HUPA-1
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: May 7, 2010
• Start date: January 2003
• Est. completion date: December 2008

Study information

• Verified date: December 2002
• Source: Hospital Universitario Principe de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Critical Care Unit. Universitary Hospital Principe de Asturias	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. N Engl J Med. 2000 May 4;342(18):1301-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Oxygenation	Evolution of arterial oxygenation during the 28 days after study randomization	28 days	Yes
Secondary	Mortality	Mortality 28 days after randomization	28 days	Yes
Secondary	Number of ventilator-free days at day 28	Number of ventilator-free days at day 28 after randomization	28 days	Yes
Secondary	multivariate analysis of mortality		28 days	No