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NOT YET RECRUITING
NCT07435389
NA

VENTILATION DURING SPACEFLIGHT (PHASE 2)

Sponsor: Centre Hospitalier Régional Metz-Thionville

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-03-16

Completion Date

2026-03-20

Last Updated

2026-02-27

Healthy Volunteers

Yes

Interventions

DEVICE

non-invasive oxygenation strategies

A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask (Intersurgical): specific settings (AI 10 cmH2O, PEEP 5 cmH2O, FiO2 21%, etc.). B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical): specific settings (AI 10 cmH2O, PEEP 5 cmH2O, FiO2 21%, etc.). C. Standard oxygen therapy without EcoLite gas mask (Intersurgical)

Locations (1)

CHR Metz-Thionville

Metz, France