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

NCT01119872 | Completed

• 1 other identifier: UCI-HUPA-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Positive-Pressure Respiration; Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

• Arterial Oxygenation

  Evolution of arterial oxygenation during the 28 days after study randomization

  28 days

Secondary Outcomes (3)

• Mortality

  28 days

• Number of ventilator-free days at day 28

  28 days

• multivariate analysis of mortality

  28 days

Study Arms (2)

Compliance-guided PEEP group

OTHER

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)

FiO2-driven-PEEP group

OTHER

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)

Interventions

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.

Also known as: Compliance-guided PEEP group: Grupo meseta, FiO2-driven-PEEP group: Grupo tabla

Compliance-guided PEEP group; FiO2-driven-PEEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Acute Respiratory Distress Syndrome (ARDS) according to the American-European Consensus Conference definition, after 24 hours under mechanical ventilation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Principe de Asturias: lead

Study Sites (1)

Critical Care Unit. Universitary Hospital Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (3)

• 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.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 340159 BACKGROUND

• 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.

  PMID: 23362167 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 10, 2010
• Study Start: January 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: May 10, 2010

Record last verified: 2002-12

Locations

ES (1)