NCT01506401

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

The Oscillation for ARDS Treated Early (OSCILLATE) Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 548 (actual)
• Sponsor: Canadian Critical Care Trials Group · Academic / Other
• Sex: All
• Age: 16 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
DEVICE	SensorMedics 3100B High Frequency Oscillatory Ventilator	High Frequency Oscillation
PROCEDURE	Lung Protective Ventilation	Tidal Volume 6ml/kg; plateau pressure \< or = 35cmH20; Prescribed PEEP/FiO2 chart

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-01-10
• Last updated: 2015-08-06

Locations

38 sites across 5 countries: United States, Canada, Chile, India, Saudi Arabia