healthy proband:in
Conditions
Interventions
Group 1: here will be five breath-hold maneuvers during the study, including the late phase with involuntary breathing movements on MRI. Four repetitions are nornecessary to measure each of the four v
Sponsors
DLR, Deutsches Zentrum für Luft- und Raumfahrt
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years Ability to hold breath till onset of IBMs
Exclusion criteria
Exclusion criteria: Pregnancy (will be tested during medical examination) MR Exclusion Criteria o Metal implants or other osteosynthesis material, stents, clips, etc. that are not MRI compatible or interfere with the examination due to their location. o Pacemakers, infusion pumps, neurostimulators, inner ear implants. o Claustrophobia. o Permanent makeup or tattoos that are not suitable for MRI. o Piercings that cannot be removed. Any clinical abnormality on medical examination o Current diseases of vital organs or the central nervous system. o Psychiatric disorders that might prevent subjects from consenting to the examination or complying with the protocol. protocol. o Regular use of medications that could affect the outcome of the study (hormonal contraceptives are not a criterion for exclusion). o Regular consumption of alcohol (20-30 g/day), nicotine (>3 cigarettes/day) or illicit drugs in Germany. o Blood donation within 3 months for women and 2 months for men prior to the study. o Clinically relevant findings in the ECG such as second or third degree AV block, prolongation of the QRS complex over 120 ms or the QTc interval over 450 ms. o Supine hypertension (> 140/90 mmHg) or hypotension (< 90/50 mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint Change in average blood flow in four main vessels (V. cava inferior, Tr. pulmonalis, Aorta ascendens, A. carotis internal) between at least two of the following time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery. One endpoint for each vessel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Change in average blood flow differences during breathing (inspiration – expiration) in the above-mentioned vessels between at least two of the following time points: baseline – early IBMs – middle IBMs – late IBMs – recovery. One endpoint for each vessel. Change in average arterial pressure (mean, systolic, diastolic) between at least two of the following time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery. One outcome for each measure. Change in average heart rate between at least two of the following time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery. Change in average peripheral oxygen saturation between at least two of the following time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery. | — |
Countries
Croatia, Germany
Contacts
Public ContactKarsten Heusser
DLRDeutsches Zentrum für Luft- und Raumfahrt
Outcome results
None listed