Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
SOLVE ARDS
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedNovember 6, 2014
November 1, 2014
1.2 years
November 6, 2013
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ventilator-Induced Lung Injury (VILI) in patients with ARDS on ECMO ventilated with different strategies (tidal ventilation, CPAP, ZEEP), as measured by Serum Cytokines
1 hour after initiation of each experimental ventilation strategy
Secondary Outcomes (4)
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)
30 minutes after initiation of experimental CPAP/ZEEP strategy
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
30 minutes after initiation of experimental CPAP/ZEEP strategy
Feasibility of lung ultrasound in patients with severe ARDS on ECMO
30 minutes after initiation of experimental CPAP/ZEEP strategy
Feasibility (patient recruitment, protocol adherence, physiologic tolerability)
At overall study completion (i.e., 24 months from study start or after enrolment of last patient)
Study Arms (2)
PHASE 1: impact of tidal ventilation on VILI
EXPERIMENTALIn 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.
PHASE 2: impact of PEEP on VILI
EXPERIMENTALIn 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).
Interventions
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
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 Criteria
You may qualify if:
- Severe ARDS (Berlin Definition)
- VV ECMO \< 72 hours
- Endotracheal intubation or tracheostomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- University Health Network, Torontocollaborator
- The Physicians' Services Incorporated Foundationcollaborator
Study Sites (1)
Medical Surgical ICU - Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 6, 2013
First Posted
November 21, 2013
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Last Updated
November 6, 2014
Record last verified: 2014-11