Trial record 6 of 9 for:    Open Studies | "Pulmonary Heart Disease"

Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Toronto
Sponsor:
Collaborators:
University Health Network, Toronto
Physicians' Services Incorporated (PSI) Foundation
Information provided by (Responsible Party):
Eddy Fan, University of Toronto
ClinicalTrials.gov Identifier:
NCT01990456
First received: November 6, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

Due to lack of studies on mechanical ventilation strategies in patients with severe Acute Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.

In this two-phases prospective, interventional, pilot study we hope to gain physiologically relevant data on two aspects of mechanical ventilation in patients with severe ARDS supported with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive End-Expiratory Pressure (PEEP).

  1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared to the current mechanical ventilation practice that employs tidal ventilation in patients with severe ARDS on ECMO.

    In this first phase we will test whether administering a distending inspiratory pressure to produce tidal ventilation is superior to a strategy where only continuous positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.

  2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP to maximize respiratory system compliance reduces VILI in patients with severe ARDS on ECMO.

In the second phase we will therefore gain more insight as to whether a strategy that utilizes a PEEP level that correspond to best compliance is beneficial over Zero End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma (serum cytokines), physiologic parameters, and right ventricular function (transesophageal echocardiographic assessment).

Because ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of imaging techniques that require transport, such as computed tomography, is limited. Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and focused bedside cardiac ultrasonography, are important tools for clinicians who care for these patients. This study will allow us to learn whether these techniques are feasible and valid in this patient population.

Furthermore, the knowledge gained from this study will allow us to assess the rationale and feasibility of performing a similar larger, randomized study in the future.


Condition Intervention
Respiratory Distress Syndrome, Adult
Device: PHASE 1: impact of tidal ventilation on VILI
Device: PHASE 2: impact of PEEP on VILI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Ventilator-Induced Lung Injury (VILI) in patients with ARDS on ECMO ventilated with different strategies (tidal ventilation, CPAP, ZEEP), as measured by Serum Cytokines [ Time Frame: 1 hour after initiation of each experimental ventilation strategy ]

Secondary Outcome Measures:
  • Impact of a CPAP strategy (PEEP set at best compliance and at ZEEP) in patients with severe ARDS on ECMO, as measured by transesophageal echocardiography (TEE) [ Time Frame: 30 minutes after initiation of experimental CPAP/ZEEP strategy ]

    Quantification of RV function:

    1. RVEDA/LVEDA
    2. LV end-diastolic/systolic eccentricity indexes:
    3. 2D RVFAC
    4. TAPSE
    5. Tissue Doppler-derived tricuspid lateral annular systolic velocity (S')
    6. RIMP
    7. 3D EF < 44%
    8. Myocardial Acceleration During Isovolumic Contraction
    9. Regional RV Strain

  • Feasibility and validity of focused cardiac ultrasound, as compared to TEE as gold standard, in the assessment of RV function in patients with ARDS on ECMO [ Time Frame: 30 minutes after initiation of experimental CPAP/ZEEP strategy ]

    Quantification of RV function:

    1. RVEDA/LVEDA
    2. TAPSE
    3. RV Annular Velocity (S')
    4. LV end-diastolic and end-systolic eccentricity indexes

  • Feasibility of lung ultrasound in patients with severe ARDS on ECMO [ Time Frame: 30 minutes after initiation of experimental CPAP/ZEEP strategy ]
    Lung Ultrasound Score

  • Feasibility (patient recruitment, protocol adherence, physiologic tolerability) [ Time Frame: At overall study completion (i.e., 24 months from study start or after enrolment of last patient) ] [ Designated as safety issue: Yes ]

    This outcome will be assessed by:

    • the ability to enrol the proposed patient sample within the timeframe of the study (24 months)
    • >90% adherence to the experimental protocol on enrolled patients
    • >80% completion of the entire experimental protocol on enrolled patients


Estimated Enrollment: 20
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PHASE 1: impact of tidal ventilation on VILI
In the first phase we will test whether administering a distending inspiratory pressure to produce tidal ventilation is superior to a strategy where only continuous positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.
Device: PHASE 1: impact of tidal ventilation on VILI
PHASE 1A - Baseline - Standard Ventilation Protocol (PCV 10 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 1B - CPAP Strategy - CPAP 10 cmH2O for 1 hour PHASE 1C - Higher Tidal Ventilation Strategy (PCV 20 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 1D - Return to Baseline - Standard Ventilation Protocol
Experimental: PHASE 2: impact of PEEP on VILI
In the second phase we will gain more insight as to whether a strategy that utilizes a PEEP level that correspond to best compliance is beneficial over Zero End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma (serum cytokines), physiologic parameters, and right ventricular function (transesophageal echocardiographic assessment).
Device: PHASE 2: impact of PEEP on VILI
PHASE 2A - Baseline - Standard Ventilation Protocol - (PCV 10 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 2B - Decremental PEEP Trial PHASE 2C - CPAP set at best compliance of respiratory system (as per decremental PEEP Trial) PHASE 2D - ZEEP PHASE 2E - Return to Baseline - Standard Ventilation Protocol

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe ARDS (Berlin Definition)
  • VV ECMO < 72 hours
  • Endotracheal intubation or tracheostomy

Exclusion Criteria:

  • Thoracic surgery/lung transplantation during the current hospitalization
  • Contraindications to a RM (MAP < 60 mmHg despite administration of fluids and vasopressors; Active air leak through a thoracostomy tube; Pneumothorax, or subcutaneous or mediastinal emphysema, (if chest tube has not been inserted))
  • Contraindications to TEE
  • Age < 16 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990456

Contacts
Contact: Fan Eddy, MD, PhD +1 416 340 4800 ext 5061 Eddy.Fan@uhn.ca
Contact: Ferguson D. Niall, MD, MSc +1 416 586 4800 ext 8449 Niall.Ferguson@uhn.ca

Locations
Canada, Ontario
Medical Surgical ICU - Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eddy Fan, MD, PhD         
Sponsors and Collaborators
University of Toronto
University Health Network, Toronto
Physicians' Services Incorporated (PSI) Foundation
Investigators
Principal Investigator: Eddy Fan, MD, PhD University Health Network, University of Toronto
Principal Investigator: Niall D. Ferguson, MD, MSc University Health Network, University of Toronto
  More Information

No publications provided

Responsible Party: Eddy Fan, MD, PhD, University of Toronto
ClinicalTrials.gov Identifier: NCT01990456     History of Changes
Other Study ID Numbers: SOLVE ARDS_01
Study First Received: November 6, 2013
Last Updated: November 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Extracorporeal Membrane Oxygenation
Ventilator-Induced Lung Injury
Ventilators, Mechanical
Pulmonary Heart Disease
Ultrasonography

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on August 28, 2014