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

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ClinicalTrials.gov Identifier: NCT02342756
Recruitment Status : Unknown
Verified January 2015 by Eddy Fan, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : January 30, 2015
Sponsor:
Collaborators:
University Health Network, Toronto
Nihon Kohden
Information provided by (Responsible Party):
Eddy Fan, University of Toronto

Brief 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.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Ventilator-Induced Lung Injury Device: Targeting transpulmonary pressure to avoid VILI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Esophageal Pressure-Guided Optimal PEEP/mPaw in CMV and HFOV: The EPOCH Study
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Group 1: CMV - HFOV

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

Device: Targeting transpulmonary pressure to avoid VILI
Set different values of PEEP (CMV) and mPaw (HFOV) to obtain determined values of transpulmonary pressure (0 and 15 centimeters of water) and to determine the impact of ventilation on VILI

Experimental: Group 2: HFOV - CMV

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

Device: Targeting transpulmonary pressure to avoid VILI
Set different values of PEEP (CMV) and mPaw (HFOV) to obtain determined values of transpulmonary pressure (0 and 15 centimeters of water) and to determine the impact of ventilation on VILI




Primary Outcome Measures :
  1. Ventilator-induced lung injury (VILI) in patients with ARDS as measured by serum cytokines [ Time Frame: 1 hour after initiation of each experimental ventilation strategy ]
    IL-6, TNF, IL-10, IL-1β, and IL-1ra and other cytokines will be detected in EDTA plasma with commercially available enzyme-linked immunosorbent assays (ELISA)


Secondary Outcome Measures :
  1. Assessment of lung recruitment and tidal overdistension [ Time Frame: 1 hour after initiation of each experimental ventilation strategy ]
    Lung ultrasound score (LUS), global and regional impedance (EIT).

  2. Impact of transpulmonary pressure on right ventricular function (RV) [ Time Frame: 1 hour after initiation of each experimental ventilation strategy ]
    Measurements: Transthoracic echocardiography (TTE).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate or severe ARDS, defined according to the Berlin definition (2);
  • Endotracheal intubation or tracheostomy

Exclusion Criteria:

  • Severe heart failure/cardiogenic shock;
  • Pulmonary arterial hypertension requiring systemic vasodilators;
  • Contraindications to esophageal balloon: esophageal pathology (stricture, perforation, high grade of varices), recent history of esophageal or gastric surgery, upper GI tract bleeding, severe coagulopathy and nasal trauma;
  • Contraindications to Electrical Impedance Tomography (EIT): a temporary or permanent pacemaker, or implantable cardioverter-defibrillator (ICD);
  • Age < 16 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342756


Locations
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Canada, Ontario
Intensive Care Unit (ICU) of Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Medical Surgical ICU - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Nihon Kohden
Investigators
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Principal Investigator: Eddy Fan, MD, PhD University Health Network, Toronto
Principal Investigator: Francesca Facchin, MD University Health Network, Toronto

Publications of Results:
Other Publications:

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Responsible Party: Eddy Fan, Eddy Fan, MD, PhD, Assistant Professor of Medicine, Interdepartmental Division of Critical Care Medicine, University of Toronto
ClinicalTrials.gov Identifier: NCT02342756     History of Changes
Other Study ID Numbers: 14-8253
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Eddy Fan, University of Toronto:
ARDS, HFOV

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries