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Acute Respiratory Distress Syndrome (ARDS)Phase 3OSCILLATENCT01506401

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

A Phase 3 study testing SensorMedics 3100B High Frequency Oscillatory Ventilator and Lung Protective Ventilation in people with Acute Respiratory Distress Syndrome (ARDS), run by Canadian Critical Care Trials Group at 38 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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)? Read more about this study

Who is it for?
Ages 16 to 85 years
What is being tested?
SensorMedics 3100B High Frequency Oscillatory Ventilator and Lung Protective Ventilation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
548 participants
Where
38 sitesin 5 countries
Study dates
Jun 2009to Sep 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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).

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

38 sites in 5 countries.

38 sites in 5 countries

Canada24 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Peter Lougheed Centre/Foothills Medical Centre

    Calgary, Alberta, T1Y 6J4

  • University of Alberta Medical Centre

    Edmonton, Alberta

  • St. Joseph's Healthcare, McMaster University

    Hamilton, Ontario, L8N 4A6

  • Hamilton Health Sciences

    Hamilton, Ontario

  • University of Western Ontario - University Hospital

    London, Ontario, N6A 5A5

  • University of Western Ontario - Victoria Hospital

    London, Ontario, N6C 6B5

  • Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Centre Hosptialier de liUniersite de Montreal - CHUM- Saint Luc

    Montreal, Quebec, H2X 3J4

  • Patrick Bellemare

    Montreal, Quebec, H4J 1C5

  • Ottawa Hospital - Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Ottawa Hospital-General Campus

    Ottawa, Ontario

  • Hopital de l'Enfant-Jesus

    Québec, Quebec, G1J 1Z4

  • Centre hospitalier universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • St Josephs

    Toronto, Ontario, M6R 1B5

  • St Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Health Science Centre

    Toronto, Ontario

  • University Health Network

    Toronto, Ontario

  • William Osler Health Centre

    Toronto, Ontario

  • St Paul's Hospital

    Vancouver, British Columbia

  • Vancouver General Hospital

    Vancouver, British Columbia

  • Vancouver Island Health Research Centre

    Victoria, British Columbia, V8R 1J8

  • Health Sciences Centre, Winnipeg

    Winnipeg, Manitoba

Other trials in Canada

United States8 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-5033

  • Parkland Memorial Hospital

    Dallas, Texas, 75390-8558

  • Denver Health Medical Centre

    Denver, Colorado, 80204

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27858

  • University of Texas HSC

    Houston, Texas, 77030

  • Orlando Regional Medical Centre

    Orlando, Florida, 32806

  • Hospital of the University ofPennsylvania

    Philadelphia, Pennsylvania, 19104

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

    Temple, Texas, 76508

Other trials in United States

Saudi Arabia3 sites

  • King Faisal Specialist Hospital & Research Centre

    Jeddah

  • King Fahad National Guard Hospital

    Riyadh

  • Riyadh Armed Forces

    Riyadh

Other trials in Saudi Arabia

Chile2 sites

  • Clinica Las Lilas

    Santiago

  • Pontificia Universidad Catolica de Chile

    Santiago

Other trials in Chile

India1 site

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune

Other trials in India

About this study

Official title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial

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)?

Read the 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.

Being tested
SensorMedics 3100B High Frequency Oscillatory Ventilator, Lung Protective Ventilation
Keywords
ARDS, ventilator-induced lung injury, lung protective ventilation, high frequency oscillation
Medical subject headings
Respiratory Distress Syndrome, Ventilator-Induced Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SensorMedics 3100B High Frequency Oscillatory VentilatorDevice

    High Frequency Oscillation

  • Lung Protective VentilationProcedure or surgery

    Tidal Volume 6ml/kg; plateau pressure < or = 35cmH20; Prescribed PEEP/FiO2 chart

Study groups in NCT01506401
Study groupRoleWhat they receive
Conventional VentilationActive comparatorLow tidal volumes, relatively high PEEP.
Receives: Procedure: Lung Protective Ventilation
High Frequency OscillationExperimentalOpen-lung strategy for high frequency oscillation.
Receives: Device: SensorMedics 3100B High Frequency Oscillatory Ventilator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause hospital mortality

    all-cause hospital mortality

    Measured: 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.

Secondary outcomes (6)

  1. Mortality at other time-points

    mortality at other time-points (ICU discharge, 60 days)

    Measured: Duration of hospitalization (ICU discharge, 60 days)

  2. Barotrauma

    Barotrauma

    Measured: ICU discharge or 60 days

  3. Organ Dysfunction

    Organ Dysfunction

    Measured: Duration of hospitalization or 60 days

  4. Duration of mechanical ventilation

    Duration of mechanical ventilation

    Measured: Duration of hospitalization or 60 days

  5. Duration of ICU & Hospital Stay

    Duration of ICU \& Hospital Stay

    Measured: Duration of hospitalization which may exceed 60 days

  6. Quality of Life at 6 months

    Quality of Life at 6 months post randomization

    Measured: 6 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2012
  4. Study completionSep 2012

Why it stopped: Enrolment halted by Steering Committee on advice from Data Monitoring Committee.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506401
Sponsor's protocol ID
MCT94829
Other IDs
ISRCTN87124254
Acronym
OSCILLATE
Status last verified
Sep 2012
First submitted
14 Dec 2011
Last updated
6 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Arabi YM, Cook DJ, Zhou Q, Smith O, Hand L, Turgeon AF, Matte A, Mehta S, Graham R, Brierley K, Adhikari NK, Meade MO, Ferguson ND; Canadian Critical Care Trials Group. Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1306-13. doi: 10.1164/rccm.201501-0172OC.

    PubMed 26192398

  • Ferguson ND, Cook DJ, Guyatt GH, Mehta S, Hand L, Austin P, Zhou Q, Matte A, Walter SD, Lamontagne F, Granton JT, Arabi YM, Arroliga AC, Stewart TE, Slutsky AS, Meade MO; OSCILLATE Trial Investigators; Canadian Critical Care Trials Group. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):795-805. doi: 10.1056/NEJMoa1215554. Epub 2013 Jan 22.

    PubMed 23339639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SensorMedics 3100B High Frequency Oscillatory Ventilator and Lung Protective Ventilation in people with Acute Respiratory Distress Syndrome (ARDS), run by Canadian Critical Care Trials Group at 38 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Canada, United States, Saudi Arabia, Chile, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Enrolment halted by Steering Committee on advice from Data Monitoring Committee.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause hospital mortality (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506401, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.

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