VENTILATION DURING SPACEFLIGHT (PHASE 2)

NCT07435389 | Not Yet Recruiting

• 1 other identifier: 2025-03-CHRMT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non-invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Expiratory tidal volume

  24 hours

Secondary Outcomes (7)

• 1. Average difference between the inspiratory assistance/PEP and the pressure

  24 hours

• 2. Number of double triggers and intra-cycle efforts

  24 hours

• 3. Average change in the "Lung volume" parameter, measured noninvasively by thoracic electrical impedance tomography (EIT)

  24 hours

• 4. Self-assessment scale for dyspnea on a scale of 1 to 10

  24 hours

• 5. CO₂-inspired tidal volume and average transcutaneous CO₂ saturation (PETCO₂)

  24 hours

Study Arms (6)

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

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)

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

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

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)

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

Device: non-invasive oxygenation strategies

Interventions

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)

ABC; ACB; BAC; BCA; CAB; CBA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals who have participated in a previous biomedical research protocol
• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville

Metz, France

Location

Central Study Contacts

Andreia CARVALHO DE FREITAS

CONTACT

0033387553323; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory study comparing the effectiveness of three non-invasive oxygenation support strategies on three groups of four people

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): October 6, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)