VENTILATION DURING SPACEFLIGHT (PHASE 2)

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).

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Key information

Conditions

Non-invasive Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville

Metz, France

Location contact

Benjamin PEQUIGNOT

CONTACT

[email protected]

00 33 87 55 31 30

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

non-invasive oxygenation strategies

Device

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)

Primary outcomes

Expiratory tidal volume

Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Andreia CARVALHO DE FREITAS

CONTACT

[email protected]

0033387553323

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: VESPA-2

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 27, 2026
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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