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Mechanical Ventilation

Ventilation Strategies in ECMO for ARDS (SOLVE ARDS Trial)

Q: Are there still vacancies available to take part in this experiment?

<p>While the trial on clinicaltrials.gov initially began recruiting patients back in September 2014 and was last edited November 5th of that same year, this particular study is not presently enrolling participants. However, there are 180 other studies looking for individuals to participate at this time.</p>

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

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

SOLVE ARDS Trial 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.Check my eligibility

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.See study design

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.

SOLVE ARDS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have a tube inserted in my windpipe for breathing.

Select...

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

Select...

I have been diagnosed with severe ARDS.

SOLVE ARDS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Secondary outcome measures

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

SOLVE ARDS 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Physicians' Services Incorporated FoundationOTHER

162 Previous Clinical Trials

26,735 Total Patients Enrolled

University Health Network, TorontoOTHER

1,468 Previous Clinical Trials

484,470 Total Patients Enrolled

5 Trials studying Respiratory Distress Syndrome

63 Patients Enrolled for Respiratory Distress Syndrome

University of TorontoLead Sponsor

689 Previous Clinical Trials

1,018,623 Total Patients Enrolled

5 Trials studying Respiratory Distress Syndrome

2,602 Patients Enrolled for Respiratory Distress Syndrome

Media Library

Respiratory Distress Syndrome Research Study Groups: PHASE 2: impact of PEEP on VILI, PHASE 1: impact of tidal ventilation on VILI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available to take part in this experiment?

"While the trial on clinicaltrials.gov initially began recruiting patients back in September 2014 and was last edited November 5th of that same year, this particular study is not presently enrolling participants. However, there are 180 other studies looking for individuals to participate at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Eddy Fan 2014. "Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01990456.

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