Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS (SUPERNOVA)
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|ClinicalTrials.gov Identifier: NCT04903262|
Recruitment Status : Not yet recruiting
First Posted : May 26, 2021
Last Update Posted : March 31, 2022
Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% in mild forms up to 46% in severe cases. Positive pressure MV remains the cornerstone of management, but at the same time it can contribute to worsening and maintenance of the lung injury when excessive stress and strain is applied to the lung parenchima (so-called ventilator-induced lung injury, VILI). VILI significantly contributes to the morbidity and mortality of ARDS patients, and it has been clearly demonstrated that protective (low-volume, low-pressure) MV settings are associated with a significant survival benefit. Unfortunately, in a certain proportion of ARDS cases, it is difficult to preserve acceptable gas exchange while maintaining protective ventilation settings, due to a high ventilatory load. In these cases, extracorporeal CO2 removal (ECCO2R) can be applied to grant the application of protective or even ultra-protective mechanical ventilation settings.
The main outcome of this multicenter, prospective, randomized, comparative open trial is to determine whether early ECCO2R allowing ultraprotective mechanical ventilation improves the outcomes of patients with moderate ARDS.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Procedure: Ultraprotective ventilation with Extracorporeal CO2 removal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Strategy of Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate ARDS: A Prospective Multicenter Randomized Clinical Trial|
|Estimated Study Start Date :||September 2022|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||December 2024|
Patients will be treated with "standardized ventilation": constant flow, assist/control; VT = 6 mL/kg PBW; insp. flow 50-70 L/min, I:E ratio 1:1 to 1:3; RR 20-35 bpm; PEEP according to "low PEEP/ high FiO2" table. Goals: PaO2 55-80 mmHg or SpO2 88-95%; arterial pH: 7.30-7.45. ECCO2R blood flow between 1000 and 1500 mL/min. Anticoagulation with unfractionated heparin to a target aPTT of 1.5 - 2.0x baseline. Target: maintain PaCO2 at baseline value ± 20% of baseline settings with a VT = 6 mL/kg provided that pH remains ≥ 7.30. Following 2-hour run-in time, VT will be reduced to 5 mL/kg. Sweep gas will be initiated and VT decreased to 4.5 then 4 mL/kg, and PEEP adjusted to reach 23 ≤ Pplat ≤ 25 cmH2O. Respiratory rate progressively decreased to a minimum of 12 bpm (eventual increases in sweep gas flow). If PaCO2 > 75 mmHg and/or pH < 7.2, despite respiratory rate of 35/min and optimized ECCO2R, VT will be increased to the last previously tolerated VT.
Procedure: Ultraprotective ventilation with Extracorporeal CO2 removal
HLS5.0 Cardiohelp® (Getinge Cardiopulmonary Care, Rastatt, Germany): 1.3 m² polymethylpentene hollow fiber membrane oxygenator. The extracorporeal blood flow is in the range of 1000 to 1500 mL/min. Sweep gas (air or oxygen) is drawn through the hollow fibers by a vacuum pump, creating a diffusion gradient for gas exchange across the membrane.
No Intervention: Standard of care
Patients will be treated with "standardized ventilation": constant flow, assist/control; VT = 6 mL/kg PBW; insp. flow 50-70 L/min, I:E ratio 1:1 to 1:3; RR 20-35 bpm; PEEP according to "low PEEP/ high FiO2" table. Goals: PaO2 55-80 mmHg or SpO2 88-95%; arterial pH: 7.30-7.45.
- Number of ventilator-free days (VFDs) at 28 days after randomization. [ Time Frame: 28 days ]VFD to-day 28 is defined as the number of days of unassisted breathing to day 28 after randomization, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
- 28-day all-cause mortality [ Time Frame: 28 days ]All patients will be classified as either "alive at Study Day 28" or, if dead, "dead at Study Day 28."
- 90-day all-cause mortality [ Time Frame: 90 days ]All patients will be classified as either "alive at Study Day 90" or, if dead, "dead at Study Day 90".
- Cumulative incidence of severe adverse events during 28 days after randomization [ Time Frame: 28 days ]Device-related and/or patient-related severe adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04903262
|Contact: Tommaso Tonetti, M.D.||+email@example.com|
|Contact: Marco Ranieri, M.D.||+firstname.lastname@example.org|
|Study Chair:||Marco Ranieri, M.D.||University of Bologna|
|Study Chair:||Antonio Pesenti, M.D.||University of Milan|