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The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial | Clinical Trials | Clareo Health

TERMINATEDPHASE3

The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial

The Oscillation for ARDS Treated Early (OSCILLATE) Trial

NCT01506401•Canadian Critical Care Trials Group

View on ClinicalTrials.gov

Summary

What is the effect of early high frequency oscillation (HFO) versus a lung-protective conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause hospital mortality among patients with severe early acute respiratory distress syndrome (ARDS)?

Detailed Description

High frequency oscillation is theoretically ideal for lung protection. Based on a strong physiological rationale, rapidly expanding use internationally, and promising results in early small RCTS, a definitive RCT to establish the impact of HFO versus current conventional ventilation on mortality is needed. We have completed a pilot multicentre RCT in preparation for this trial, with goals of investigating patient recruitment, protocol acceptance, and crossover rates. The pilot study met all objectives including recruitment that exceeded expectations (94 patients), and very good adherence to protocol. Results of the multinational OSCILLATE Trial will establish the impact of HFO versus conventional ventilation on mortality rates among adults with severe ARDS.

Eligibility

Age

16 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
•Endotracheal intubation or tracheostomy;
•Hypoxaemia - defined as a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) less than or equal to 200mmHg on FiO2 greater than or equal to 0.5, regardless of positive end expiratory pressure (PEEP)
•Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph
•In addition, to qualify for randomization, patients are assessed on the following ventilator settings:
•Mode: pressure control or volume control or pressure support
•FiO2 greater than 0.6 (or higher if necessary to keep pulse oximetric saturation \[SpO2\] greater than 90%)
•PEEP greater than 10 cm H2O (or greater if necessary to keep SpO2 greater than 90%)
•Tidal volume 6 ml/kg predicted body weight (PBW)
•After at least 30 minutes on these settings, we sample arterial blood to assess oxygenation. If PaO2 is less than or equal to 200 mmHg, the patient qualifies for randomization; if PaO2/FiO2 greater than 200 mmHg, standardized hypoxaemia assessments are repeated at least once daily for the following 72 hours (providing eligibility criteria are still met).
+1 more criteria

Exclusion Criteria

•Remaining duration of mechanical ventilation less than 48 hours, as judged by the attending physician
•Primary cause of acute respiratory failure judged by attending physician to be circulatory overload due to, for example, congestive heart failure, hyper-resuscitation, or need for dialysis
•Suspected pulmonary haemorrhage syndrome
•Lack of commitment to ongoing life support (note that this does not include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support
•Aged less than 16 years or greater than 85 years
•Weight less than 35 kg
•Severe chronic respiratory disease, as indicated by any of:
•Baseline forced expiratory volume in one second (FEV1) less than 20 ml/kg predicted body weight
•Pre-existing chronic interstitial lung disease with chronic interstitial infiltration on chest x-ray
•Documented chronic carbon dioxide (CO2) retention (partial pressure of carbon dioxide in arterial blood \[PaCO2\] less than 50 mmHg) and/or chronic hypoxaemia(PaO2 less than 55 mmHg on FiO2=0.21)
+8 more criteria

Locations (38)

Denver Health Medical Centre

Denver, Colorado, United States

Orlando Regional Medical Centre

Orlando, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Hospital of the University ofPennsylvania

Philadelphia, Pennsylvania, United States

Parkland Memorial Hospital

Dallas, Texas, United States

University of Texas HSC

Houston, Texas, United States

Texas A&M HSC College of Medicine, Scott & White Hospital

Temple, Texas, United States

Peter Lougheed Centre/Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Medical Centre

Edmonton, Alberta, Canada

Key Dates

Start Date

June 1, 2009

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

August 6, 2015

Enrollment

548

ACTUAL participants

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

SensorMedics 3100B High Frequency Oscillatory Ventilator

DEVICE

Lung Protective Ventilation

PROCEDURE

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Acute Respiratory Distress Syndrome (ARDS)

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RECRUITINGPHASE2

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

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Acute Respiratory Distress Syndrome (ARDS)ARDS+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial

Inclusion Criteria

Exclusion Criteria

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury

A Trial of Staff Time With Proned Patients in the ICU Using the 'BathMat'

RecruitmEnt Assessed by eleCtRical Impedance Tomography

Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome