Esophageal Pressure-Guided Optimal PEEP/mPaw in CMV and HFOV: The EPOCH Study
(EPOCH Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byFrancesca Facchin, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Moderate or severe ARDS, defined according to the Berlin definition (2);

Endotracheal intubation or tracheostomy

Treatment Details

Interventions

Transpulmonary pressure targeting device (Device)

Participant Groups

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