An interventional study of non-invasive oxygenation strategies in Non-invasive Ventilation, sponsored by Centre Hospitalier Régional Metz-Thionville. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Other
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).
Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) C. Standard oxygen therapy without EcoLite gas mask
Device: non-invasive oxygenation strategies
A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask C. Standard oxygen therapy without EcoLite gas mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical)
Device: non-invasive oxygenation strategies
B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) A . Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask C. Standard oxygen therapy without EcoLite gas mask
Device: non-invasive oxygenation strategies
B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) C. Standard oxygen therapy without EcoLite gas mask A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask
Device: non-invasive oxygenation strategies
C. Standard oxygen therapy without EcoLite gas mask A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical)
Device: non-invasive oxygenation strategies
C. Standard oxygen therapy without EcoLite gas mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask
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)
Expiratory tidal volume
Time frame: 24 hours
1. Average difference between the inspiratory assistance/PEP and the pressure
Measured by the pneumotachograph during the last 5 respiratory cycles of the 22-second weightlessness phase
Time frame: 24 hours
2. Number of double triggers and intra-cycle efforts
during the last 5 respiratory cycles of the 22-second weightlessness phase, as observed when reading the curves on the pneumotachograph
Time frame: 24 hours
3. Average change in the "Lung volume" parameter, measured noninvasively by thoracic electrical impedance tomography (EIT)
During the last 5 respiratory cycles of the 22-second weightlessness phase
Time frame: 24 hours
4. Self-assessment scale for dyspnea on a scale of 1 to 10
To be evaluated at the end of the 22-second run (Numeric Rating Scale (NRS)) 0 = no dyspnea 10 = maximum imaginable dyspnea
Time frame: 24 hours
5. CO₂-inspired tidal volume and average transcutaneous CO₂ saturation (PETCO₂)
over the last 5 respiratory cycles during the 22-second weightlessness phase, as measured by a capnostat and by transcutaneous CO₂ measurement
Time frame: 24 hours
6. Occurrence of an adverse event: PETCO2 > 50 mmHg
dyspnea score \> 8/10, or nausea (yes/no on questioning)
Time frame: 48 hours
7.The average respiratory
Rate over the last 5 respiratory cycles during the 22-second weightless phase.
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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