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VENTILATION DURING SPACEFLIGHT (PHASE 2)

Study acronym: VESPA-2
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 25, 2026 (before its estimated October 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Primary and study completion dates: Sep 20, 2026 to Oct 10, 2026
    • Start date: Sep 16, 2026 to Oct 6, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints expanded, about 69 words
  2. Notable Primary and study completion pushed from Mar 20, 2026 to Sep 20, 2026
    • Start date: Mar 16, 2026 to Sep 16, 2026
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Space flights expose astronauts to medical risks, particularly respiratory risks, which are exacerbated in microgravity. Devices such as standard oxygen therapy and non-invasive ventilation (NIV) are used, but their performance in microgravity remains poorly studied. Parabolic flights allow these technologies to be evaluated in conditions similar to those encountered during space missions. In an initial study conducted in microgravity during a parabolic flight campaign, the T1 ventilator proved superior to the other devices tested on the test bench. However, its performance in healthy volunteers has not yet been evaluated. The central hypothesis of this exploratory study on healthy volunteers is that non-invasive ventilation, particularly with the CaStar UP helmet (Intersurgical), could offer superior performance to the standard oxygen mask in microgravity, thanks to better leak reduction (data from preclinical work on a test bench).
Trial Details
NCT Number NCT07435389
Lead Sponsor Centre Hospitalier Régional Metz-Thionville
Conditions
(from sponsor)
Non-invasive Ventilation
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov