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Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS

Study acronym: SUPERNOVA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Start date changed from estimate of Jun 1, 2024 to Dec 1, 2024
    • Study sites: 0 to 1
    • Study completion date: Mar 31, 2026 to Mar 31, 2027
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Start date: Apr 30, 2023 to Jun 1, 2024
    • Study completion date: Mar 31, 2025 to Mar 31, 2026
    v7
  3. Start date: Jan 1, 2023 to Apr 30, 2023
    • Eligibility criteria expanded, about 5 words
    v6
  4. Study completion date: Jun 30, 2025 to Mar 31, 2025v5
  5. Start date: Sep 2022 to Jan 1, 2023v4 Show 6 more changesShow less
    • Primary completion date: Sep 2024 to Dec 31, 2024
    • Study completion date: Dec 2024 to Jun 30, 2025
    • Interventions: Ultraprotective ventilation with Extracorporeal CO2 removal (Procedure) to Conventional protective ventilation (Procedure), Ultraprotective ventilation with Extracorporeal CO2 removal (Procedure)
    • Eligibility criteria revised
    • Study description expanded, about 1,196 words
    • Collaborators expanded, about 2 words
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Sep 2023 to Sep 2024
    • Start date: Sep 2021 to Sep 2022
    • Study completion date: Dec 2023 to Dec 2024
    v3
  2. Study description shortened, about 19 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04903262
Lead Sponsor University of Bologna
Collaborators: Getinge Group
Conditions
(from sponsor)		 Acute Respiratory Distress Syndrome
Related terms Respiratory Distress Syndrome
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov