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

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— OSCILLATE  

Official title:

The Oscillation for ARDS Treated Early (OSCILLATE) Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01506401
• Other study ID #: MCT94829
• Secondary ID: ISRCTN87124254
• Status: Terminated
• Phase: Phase 3
• First received: December 14, 2011
• Last updated: August 5, 2015
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Canadian Critical Care Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 548
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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).

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)

• Chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (e.g., unable to climb stairs or perform household duties), secondary polycythaemia, severe pulmonary hypertension (mean pulmonary arterial pressure [PAP] greater than 40 mmHg), or ventilator dependency

• Morbid obesity - defined as greater than 1 kg/cm body height

• Underlying pre-existing condition with expected 6-month mortality greater than 50%

• Neurological conditions with risk of intracranial hypertension (where hypercapnia should be avoided)

• Neuromuscular disease that will result in prolonged need for mechanical ventilation, including (but not limited to):

• Guillain Barre syndrome

• Cervical spinal cord injury

• Previous randomization in this trial

• All inclusion criteria present for greater than 73 hours in study intensive care unit (ICU)

• On HFO at the time of screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	Peter Lougheed Centre/Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Medical Centre	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare, McMaster University	Hamilton	Ontario
Canada	University of Western Ontario - University Hospital	London	Ontario
Canada	University of Western Ontario - Victoria Hospital	London	Ontario
Canada	Centre Hosptialier de liUniersite de Montreal - CHUM- Saint Luc	Montreal	Quebec
Canada	Maisonneuve Rosemont	Montreal	Quebec
Canada	Patrick Bellemare	Montreal	Quebec
Canada	Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	Ottawa Hospital-General Campus	Ottawa	Ontario
Canada	Hopital de l'Enfant-Jesus	Quebec
Canada	Centre hospitalier universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St Josephs	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	William Osler Health Centre	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Vancouver Island Health Research Centre	Victoria	British Columbia
Canada	Health Sciences Centre, Winnipeg	Winnipeg	Manitoba
Chile	Clinica Las Lilas	Santiago
Chile	Pontificia Universidad Catolica de Chile	Santiago
India	Deenanath Mangeshkar Hospital & Research Centre	Pune
Saudi Arabia	King Faisal Specialist Hospital & Research Centre	Jeddah
Saudi Arabia	King Fahad National Guard Hospital	Riyadh
Saudi Arabia	Riyadh Armed Forces	Riyadh
United States	University of Michigan	Ann Arbor	Michigan
United States	Parkland Memorial Hospital	Dallas	Texas
United States	Denver Health Medical Centre	Denver	Colorado
United States	Brody School of Medicine at East Carolina University	Greenville	North Carolina
United States	University of Texas HSC	Houston	Texas
United States	Orlando Regional Medical Centre	Orlando	Florida
United States	Hospital of the University ofPennsylvania	Philadelphia	Pennsylvania
United States	Texas A&M HSC College of Medicine, Scott & White Hospital	Temple	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Canadian Critical Care Trials Group	Canadian Institutes of Health Research (CIHR), McMaster University, University of Toronto

Countries where clinical trial is conducted

United States,  Canada,  Chile,  India,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause hospital mortality	all-cause hospital mortality	Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.	Yes
Secondary	Mortality at other time-points	mortality at other time-points (ICU discharge, 60 days)	Duration of hospitalization (ICU discharge, 60 days)	Yes
Secondary	Barotrauma	Barotrauma	ICU discharge or 60 days	Yes
Secondary	Organ Dysfunction	Organ Dysfunction	Duration of hospitalization or 60 days	Yes
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation	Duration of hospitalization or 60 days	Yes
Secondary	Duration of ICU & Hospital Stay	Duration of ICU & Hospital Stay	Duration of hospitalization which may exceed 60 days	Yes
Secondary	Quality of Life at 6 months	Quality of Life at 6 months post randomization	6 months post randomization	No