Health TrialsbyHealthPanel

VENTILATION DURING SPACEFLIGHT (PHASE 2)

ConditionNon-invasive Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

12 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ABCExperimental treatment 1 intervention
Group B: ACBExperimental treatment 1 intervention
Group C: BACExperimental treatment 1 intervention
Group D: BCAExperimental treatment 1 intervention
Group E: CABExperimental treatment 1 intervention
Group F: CBAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Expiratory tidal volume

Time frame
24 hours

Secondary outcomes

1

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

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

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Régional Metz-Thionville

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: