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Completed

NCT Number: NCT00474656

The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Medical Centre, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of either sex, 16 years and above;
  • Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
  • Endotracheal intubation or tracheostomy;
  • Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg;
  • Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph

Exclusion criteria

  • Remaining duration of mechanical ventilation < 48 hours, as judged by the attending physician;
  • Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin;
  • Lack of commitment to ongoing life support;
  • Weight < 35 kg;
  • Severe chronic respiratory disease
  • Morbid obesity - defined as > 1 kg / cm body height;
  • Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided);
  • Neuromuscular disease that will result in prolonged need for mechanical ventilation;
  • Previous enrolment in this trial;
  • All inclusion criteria present for > 72 hours;
  • On HFO at the time of screening.

Treatment and study plan

High-frequency oscillation

Device

Conventional lung-open mechanical ventilation

Device

Primary outcomes

  1. adherence to our explicit mechanical ventilation protocols;

    Time frame: duration of mechanical ventilation

  2. to measure and understand the reasons for crossovers between groups

    Time frame: duration of mechanical ventilation

  3. to estimate the rate of patient recruitment, and understand barriers to recruitment

  4. to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment

Sponsors and collaborators

Lead sponsor

Canadian Critical Care Trials Group

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • McMaster University
  • University of Toronto

Registry information

Acronym: OSCILLATE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 17, 2007
Registry last updated
Jan 30, 2009

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

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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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