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Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE)

Study acronym: COPD-SAFE
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated October 15, 2024 (before its estimated February 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 2023 to Feb 2025
    • Start date: Jun 2023 to Dec 2024
    • Study completion date: Mar 2024 to Feb 2025
    v7
  2. Primary completion date: Dec 2021 to Dec 2023
    • Start date: Jun 2021 to Jun 2023
    • Study completion date: Mar 2022 to Mar 2024
    v6
  3. Start date: Mar 2021 to Jun 2021
    • Primary completion date: Sep 2021 to Dec 2021
    • Study completion date: Sep 2021 to Mar 2022
    v5
  4. Primary and study completion dates: Sep 2020 to Sep 2021
    • Start date: Mar 2020 to Mar 2021
    v4
  5. Start date: Oct 2019 to Mar 2020
    • Primary and study completion dates: Aug 2020 to Sep 2020
    v3
  6. Secondary endpoints: 4 to 1v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.
Trial Details
NCT Number NCT04089111
Lead Sponsor Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Positive-Pressure Respiration, Intrinsic, Pulmonary Disease, Chronic Obstructive
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov