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Device

Group 1: CMV - HFOV for Respiratory Distress Syndrome (EPOCH Trial)

N/A
Waitlist Available
Led By Francesca Facchin, MD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate or severe ARDS, defined according to the Berlin definition (2);
Endotracheal intubation or tracheostomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after initiation of each experimental ventilation strategy
Awards & highlights

EPOCH Trial Summary

The use of positive end-expiratory pressure (PEEP) has been shown to prevent the cycling end-expiratory collapse during mechanical ventilation and to maintain alveolar recruitment, keeping lung portions open, increasing the resting end-expiratory volume. On the other hand PEEP may also overdistend the already open lung, increasing stress and strain. Theoretically high frequency oscillatory ventilation (HFOV) could be considered an ideal strategy in patients with ARDS for the small tidal volumes, but the expected benefits have not been shown yet. PEEP and HFOV should be tailored on individual physiology. Assuming that the esophageal pressure is a good estimation of pleural pressure, transpulmonary pressure can be estimated by the difference between airway pressure and esophageal pressure (PL= Paw - Pes). A PL of 0 cmH2O at end-expiration should keep the airways open (even if distal zones are not certainly recruited) and a PL of 15 cmH2O should produce an overall increase of lung recruitment. The investigators want to determine whether the prevention of atelectrauma by setting PEEP and mPaw to obtain 0 cmH2O of transpulmonary pressure at end expiratory volume is less injurious than lung recruitment limiting tidal overdistension by setting PEEP and mPaw at a threshold of 15 cmH2O of transpulmonary pressure. The comparison between conventional ventilation with tidal volume of 6 ml/Kg and HFOV enables us to understand the role of different tidal volumes on preventing atelectrauma and inducing lung recruitment. The use of non-invasive bedside techniques such as lung ultrasound, electrical impedance tomography, and transthoracic echocardiography are becoming necessary in ICU and may allow us to distinguish between lung recruitment and tidal overdistension at different PEEP/mPaw settings, in order to limit pulmonary and hemodynamic complications during CMV and HFOV.

Eligible Conditions
  • Respiratory Distress Syndrome
  • Ventilator-Induced Lung Injury

EPOCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

EPOCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after initiation of each experimental ventilation strategy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after initiation of each experimental ventilation strategy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ventilator-induced lung injury (VILI) in patients with ARDS as measured by serum cytokines
Secondary outcome measures
Assessment of lung recruitment and tidal overdistension
Impact of transpulmonary pressure on right ventricular function (RV)

EPOCH Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: HFOV - CMVExperimental Treatment1 Intervention
Patients in group 2 will start with high frequency oscillatory ventilation (D- mPaw so that PL = 0 cmH2O, E- mPaw so that PL = 15 cmH2O, F- mPaw so that PL = 0 cmH2O) and then will be ventilated with conventional mechanical ventilation with different values of PEEP (A-PEEP so that PLEEO = 0 cmH2O, B- PEEP so that PLEIO = 15 cmH2O, C- PEEP so that PLEEO = 0 cmH2O). Intervention: Device: Targeting transpulmonary pressure to avoid VILI
Group II: Group 1: CMV - HFOVExperimental Treatment1 Intervention
Patients in group 1 will start with conventional mechanical ventilation with different values of PEEP (A-PEEP so that PLEEO = 0 cmH2O, B- PEEP so that PLEIO = 15 cmH2O, C- PEEP so that PLEEO = 0 cmH2O) and then will be ventilated with high frequency oscillatory ventilation (D- mPaw so that PL = 0 cmH2O, E- mPaw so that PL = 15 cmH2O, F- mPaw so that PL = 0 cmH2O) Intervention: Device: Targeting transpulmonary pressure to avoid VILI

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
687 Previous Clinical Trials
1,018,275 Total Patients Enrolled
5 Trials studying Respiratory Distress Syndrome
2,602 Patients Enrolled for Respiratory Distress Syndrome
University Health Network, TorontoOTHER
1,456 Previous Clinical Trials
482,779 Total Patients Enrolled
5 Trials studying Respiratory Distress Syndrome
63 Patients Enrolled for Respiratory Distress Syndrome
Nihon KohdenIndustry Sponsor
17 Previous Clinical Trials
1,053 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby Mar 2025