Respiratory Distress Syndrome, AdultSOLVE ARDSNCT01990456
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
A study testing PHASE 1: impact of tidal ventilation on VILI and PHASE 2: impact of PEEP on VILI in people with Respiratory Distress Syndrome, Adult, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- PHASE 1: impact of tidal ventilation on VILI and PHASE 2: impact of PEEP on VILI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe ARDS (Berlin Definition)
- VV ECMO < 72 hours
- Endotracheal intubation or tracheostomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Medical Surgical ICU - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Eddy Fan, MD, PhD
About this study
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).
Read more
- 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.
- 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- PHASE 1: impact of tidal ventilation on VILI, PHASE 2: impact of PEEP on VILI
- Keywords
- Extracorporeal Membrane Oxygenation, Ventilator-Induced Lung Injury, Ventilators, Mechanical, Pulmonary Heart Disease, Ultrasonography
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury, Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHASE 1: impact of tidal ventilation on VILIDevice
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 2: impact of PEEP on VILIDevice
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
| Study group | Role | What they receive |
|---|---|---|
| PHASE 1: impact of tidal ventilation on VILI | Experimental | 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. Receives: Device: PHASE 1: impact of tidal ventilation on VILI |
| PHASE 2: impact of PEEP on VILI | Experimental | 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). Receives: Device: PHASE 2: impact of PEEP on VILI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Induced Lung Injury (VILI) in patients with ARDS on ECMO ventilated with different strategies (tidal ventilation, CPAP, ZEEP), as measured by Serum Cytokines
Measured: 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)
Quantification of RV function:
- RVEDA/LVEDA
- LV end-diastolic/systolic eccentricity indexes:
- 2D RVFAC
- TAPSE
- Tissue Doppler-derived tricuspid lateral annular systolic velocity (S')
- RIMP
- 3D EF < 44%
- Myocardial Acceleration During Isovolumic Contraction
- Regional RV Strain
Measured: 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
Quantification of RV function:
- RVEDA/LVEDA
- TAPSE
- RV Annular Velocity (S')
- LV end-diastolic and end-systolic eccentricity indexes
Measured: 30 minutes after initiation of experimental CPAP/ZEEP strategy
Feasibility of lung ultrasound in patients with severe ARDS on ECMO
Lung Ultrasound Score
Measured: 30 minutes after initiation of experimental CPAP/ZEEP strategy
Feasibility (patient recruitment, protocol adherence, physiologic tolerability)
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
Measured: At overall study completion (i.e., 24 months from study start or after enrolment of last patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Eddy Fan, University of Toronto
- Investigators
- Eddy Fan, MD, PhD, Principal investigator, University Health Network, University of TorontoNiall D. Ferguson, MD, MSc, Principal investigator, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990456
- Sponsor's protocol ID
- SOLVE ARDS_01
- Acronym
- SOLVE ARDS
- Status last verified
- Nov 2014
- First submitted
- 6 Nov 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
- ClinicalTrials.gov ID
- NCT01990456
- Acronym / sponsor ID
- SOLVE ARDS / SOLVE ARDS_01
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Extracorporeal Membrane Oxygenation, Ventilator-Induced Lung Injury, Ventilators, Mechanical, Pulmonary Heart Disease, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, The Physicians' Services Incorporated Foundation
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHASE 1: impact of tidal ventilation on VILI | Experimental | Device: PHASE 1: impact of tidal ventilation on VILIIn 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 | Experimental | Device: PHASE 2: impact of PEEP on VILIIn 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Severe ARDS (Berlin Definition)
- VV ECMO < 72 hours
- Endotracheal intubation or tracheostomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHASE 1: impact of tidal ventilation on VILIPHASE 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 | Device | PHASE 1: impact of tidal ventilation on VILI |
| PHASE 2: impact of PEEP on VILIPHASE 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 | Device | PHASE 2: impact of PEEP on VILI |
Primary outcome
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
4 secondary outcomes
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
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
Feasibility of lung ultrasound in patients with severe ARDS on ECMO
Time frame: 30 minutes after initiation of experimental CPAP/ZEEP strategy
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddy Fan, MD, PhD principal investigator
University Health Network, University of Toronto
Niall D. Ferguson, MD, MSc principal investigator
University Health Network, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHASE 1: impact of tidal ventilation on VILI and PHASE 2: impact of PEEP on VILI in people with Respiratory Distress Syndrome, Adult, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Eddy, MD, PhD (+1 416 340 4800 ext. 5061, Eddy.Fan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.