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Effects of involuntary breathing movements on central blood flow

Recruiting
Conditions
healthy proband:in
Registration Number
DRKS00028611
Lead Sponsor
DLR, Deutsches Zentrum für Luft- und Raumfahrt
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
25
Inclusion Criteria

Age = 18 years
Ability to hold breath till onset of IBMs

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).

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary endpoint <br>Change in average blood flow in four main vessels (V. cava inferior, Tr. pulmonalis, Aorta <br>ascendens, A. carotis internal) between at least two of the following time points: baseline – <br>early apnea – early IBMs – middle IBMs – late IBMs – recovery. One endpoint for each vessel.
Secondary Outcome Measures
NameTimeMethod
Secondary endpoints <br>Change in average blood flow differences during breathing (inspiration – expiration) in the <br>above-mentioned vessels between at least two of the following time points: baseline – early <br>IBMs – middle IBMs – late IBMs – recovery. One endpoint for each vessel. <br>Change in average arterial pressure (mean, systolic, diastolic) between at least two of the <br>following time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery. <br>One outcome for each measure. <br>Change in average heart rate between at least two of the following time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery. <br>Change in average peripheral oxygen saturation between at least two of the following <br>time points: baseline – early apnea – early IBMs – middle IBMs – late IBMs – recovery.
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