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Mechanical Ventilation

Ventilation Strategies in ECMO for ARDS (SOLVE ARDS Trial)

N/A

Waitlist Available

Led By Niall D. Ferguson, MD, MSc

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Endotracheal intubation or tracheostomy

VV ECMO < 72 hours

Must not have

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))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at overall study completion (i.e., 24 months from study start or after enrolment of last patient)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the best way to ventilate patients with severe ARDS who are supported by Veno-Venous ECMO. The two phases will study the impact of tidal ventilation and the level of Positive End-Expiratory Pressure on VILI, with the goal of reducing lung injury.

Who is the study for?

This trial is for patients with severe ARDS who have been on VV ECMO for less than 72 hours and are intubated. It's not for those under 16, with recent thoracic surgery/lung transplant, contraindications to recruitment maneuvers or TEE, active air leaks, pneumothorax without a chest tube, or unstable blood pressure.

What is being tested?

The SOLVE ARDS study tests mechanical ventilation strategies in two phases: Phase 1 compares tidal ventilation against CPAP only; Phase 2 examines the effects of different PEEP levels. Both phases assess impact on lung injury using serum cytokines and other physiological measures.

What are the potential side effects?

Potential side effects may include increased biotrauma from improper ventilator settings leading to worsening lung injury. The use of transesophageal echocardiography (TEE) could also pose risks such as throat discomfort or rare complications like esophageal perforation.

Eligibility Criteria

Inclusion Criteria

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

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I have a tube inserted in my windpipe for breathing.

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I have been on VV ECMO for less than 72 hours.

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I have been diagnosed with severe ARDS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am undergoing or have undergone lung surgery or transplantation in my current hospital stay.

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I do not have low blood pressure, air leaks in my chest, or air trapped in the chest wall that cannot be treated with a chest tube.

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I am younger than 16 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at overall study completion (i.e., 24 months from study start or after enrolment of last patient)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at overall study completion (i.e., 24 months from study start or after enrolment of last patient)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at overall study completion (i.e., 24 months from study start or after enrolment of last patient) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Feasibility (patient recruitment, protocol adherence, physiologic tolerability)

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

Feasibility of lung ultrasound in patients with severe ARDS on ECMO

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PHASE 2: impact of PEEP on VILIExperimental Treatment1 Intervention

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).

Group II: PHASE 1: impact of tidal ventilation on VILIExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met