Non-invasive VentilationVESPA-2NCT07435389
VENTILATION DURING SPACEFLIGHT (PHASE 2)
A study testing non-invasive oxygenation strategies in people with Non-invasive Ventilation, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Ventilation
- What is being tested?
- non-invasive oxygenation strategies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2026to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (male or female)
- Aged 18 to 65
- Affiliated with a Social Security scheme and, for non-French residents, holders of a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC)
- Agreeing to participate in the study
- Agreeing to participate in the study
- Having given their informed consent in writing
- Who have undergone a medical examination similar to a standard aeronautical medical examination for private pilot fitness
Who cannot join
- Individuals who have participated in a previous biomedical research protocol
- whose exclusion period has not ended.
- Individuals in a subordinate relationship with the principal investigator or scientific director.
- Pregnant or breastfeeding women (urine pregnancy test for women of childbearing age).
- Protected adults (under guardianship, curatorship, or judicial protection)
- Flu-like symptoms, digestive symptoms (nausea, vomiting), fever.
- Altered mental state (flight-related anxiety, phobic state).
- Failure to attend the Novespace safety briefing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHR Metz-Thionville
Metz
Benjamin PEQUIGNOT, 00 33 87 55 31 30, benjamin.pequignot@chr-metz-thionville.fr
About this study
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).
- Conditions
- Non-invasive Ventilation
- Being tested
- non-invasive oxygenation strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive oxygenation strategiesDevice
- 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)
| Study group | Role | What they receive |
|---|---|---|
| ABC | Experimental | 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 Receives: Device: non-invasive oxygenation strategies |
| ACB | Experimental | 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) Receives: Device: non-invasive oxygenation strategies |
| BAC | Experimental | 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 Receives: Device: non-invasive oxygenation strategies |
| BCA | Experimental | 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 Receives: Device: non-invasive oxygenation strategies |
| CAB | Experimental | 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) Receives: Device: non-invasive oxygenation strategies |
| CBA | Experimental | 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 Receives: Device: non-invasive oxygenation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory tidal volume
Measured: 24 hours
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
6. Occurrence of an adverse event: PETCO2 > 50 mmHg
dyspnea score > 8/10, or nausea (yes/no on questioning)
Measured: 48 hours
7.The average respiratory
Rate over the last 5 respiratory cycles during the 22-second weightless phase.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start6 Oct 2026 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Exploratory study comparing the effectiveness of three non-invasive oxygenation support strategies on three groups of four people
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435389
- Sponsor's protocol ID
- 2025-03-CHRMT
- Acronym
- VESPA-2
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENTILATION DURING SPACEFLIGHT (PHASE 2)
- ClinicalTrials.gov ID
- NCT07435389
- Acronym / sponsor ID
- VESPA-2 / 2025-03-CHRMT
- Conditions
- Non-invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 6 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Exploratory study comparing the effectiveness of three non-invasive oxygenation support strategies on three groups of four people
| Arm | Type | Receives |
|---|---|---|
| ABC | Experimental | Device: non-invasive oxygenation strategiesA. 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 |
| ACB | Experimental | Device: non-invasive oxygenation strategiesA. 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) |
| BAC | Experimental | Device: non-invasive oxygenation strategiesB. 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 |
| BCA | Experimental | Device: non-invasive oxygenation strategiesB. 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 |
| CAB | Experimental | Device: non-invasive oxygenation strategiesC. 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) |
| CBA | Experimental | Device: non-invasive oxygenation strategiesC. 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers (male or female)
- Aged 18 to 65
- Affiliated with a Social Security scheme and, for non-French residents, holders of a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC)
- Agreeing to participate in the study
- Agreeing to participate in the study
Key exclusion criteria (8 listed)
- Individuals who have participated in a previous biomedical research protocol
- whose exclusion period has not ended.
- Individuals in a subordinate relationship with the principal investigator or scientific director.
- Pregnant or breastfeeding women (urine pregnancy test for women of childbearing age).
- Protected adults (under guardianship, curatorship, or judicial protection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive oxygenation strategiesA. 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) | Device | ABC, ACB, BAC, BCA, CAB, CBA |
Primary outcome
Expiratory tidal volume
Time frame: 24 hours
7 secondary outcomes
1. Average difference between the inspiratory assistance/PEP and the pressure
Time frame: 24 hours
2. Number of double triggers and intra-cycle efforts
Time frame: 24 hours
3. Average change in the "Lung volume" parameter, measured noninvasively by thoracic electrical impedance tomography (EIT)
Time frame: 24 hours
4. Self-assessment scale for dyspnea on a scale of 1 to 10
Time frame: 24 hours
5. CO₂-inspired tidal volume and average transcutaneous CO₂ saturation (PETCO₂)
Time frame: 24 hours
6. Occurrence of an adverse event: PETCO2 > 50 mmHg
Time frame: 48 hours
7.The average respiratory
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive oxygenation strategies in people with Non-invasive Ventilation, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreia CARVALHO DE FREITAS (0033387553323, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory tidal volume (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.