- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01993394
Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Experiments were conducted in a human centrifuge. The protocol aimed at mimicking a routine peacetime flight in combat aircraft, and included 10-min exposure to +1.4 - +3.5 Gz. Subjects were exposed three times to this sequence, breathing air, 44.5% O2 or 100% O2.
Ten volunteers wearing anti-G trousers participated in the study. The Ethics Committee Ile-de-France III and the French National Agency for Drug Safety (ANSM) approved the protocol (number 2009-A01092-55).
Three different imaging techniques, electrical impedance tomography (EIT), pulmonary ultrasound and chest SPECT/CT were used and compared. EIT enabled ventilation monitoring in the human centrifuge, whereas pulmonary ultrasound and SPECT/CT gave functional and topographical information before and after exposure to +Gz accelerations. EIT analysis focused on regional ventilation, SPECT on global lung ventilation and perfusion, CT on the presence of atelectasis, and pulmonary ultrasound analysis looked for comet tails in 64 chest areas. Arterial blood pressure was recorded continuously by finger photoplethysmography. Cardiac output and stroke volume were computed from these recordings, using three different algorithms. Echocardiography was used as reference non-invasive technique for stroke volume determination and performed before and after exposure to +Gz accelerations.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Brétigny-sur-Orge, Frankrike, 91 223
- Armed Forces Biomedical Research Institute
-
Paris, Frankrike, 75005
- Department of Nuclear Medicine, Val-de-Grâce hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- normal lung function checked by pulmonary function tests
Part 1 exclusion Criteria:
- past medical history of heart or lung disease
- current medical treatment for heart or lung disease
- smoking
- bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
Part 2 exclusion criteria:
- past medical history of heart or lung disease
- current medical treatment for heart or lung disease
- smoking
- The use of medication for hypertension
- asymmetric values of left/right humeral arterial blood pressure
- significant echocardiographic abnormalities or bad echogenicity
- bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ventilation
hypergravity gas mixture
|
1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
breathing air, 44.5%O2 or 100%O2
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in regional ventilation distribution
Tidsram: baseline, 2hrs 30min
|
"per lobe and per quadrant at 5th intercostal space level"
|
baseline, 2hrs 30min
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in regional pulmonary perfusion
Tidsram: baseline, 2hrs 30min
|
"per lobe and per quadrant at 5th intercostal space level"
|
baseline, 2hrs 30min
|
|
cardiac output (L/min)
Tidsram: 2hrs
|
"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"
|
2hrs
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
tidal volume
Tidsram: 2hrs 30min
|
global (mL, area under the flow versus time curve) and regional (% change per quadrant at 5th intercostal space level)
|
2hrs 30min
|
Samarbetspartners och utredare
Utredare
- Studiestol: Daniel Garin, MD, PhD, Armed Forces Biomedical Research Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10co706
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