Ignite Creation Date:
2024-05-06 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03574675
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-06-20
Brief Title:
Acute Exposure of Simulated Hypoxia on Cardiac Output
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized crossover trial in patients with Pulmonary Hypertension PAH CTEPH to assess the acute response to simulated altitude FIO2 151 equivalent to 2500m above sea level on non-invasive cardiac output assessments by Finapres NOVA Technology at rest and under exercise
Detailed Description:
Low altitude baseline measurements will be performed in Zurich 470m asl including Echocardiography right heart catheterization six-minute walk test 6MWT pulmonary function test clinical assessment and blood gas analysis at rest and under exercise
Randomly assigned to the order of testing the participants will be tested under simulated altitude FiO2 151 with the AMC Altitrainer and shamed altitude with the same device
During the exposure to simulated altitude FiO2 151 and shamed altitude of 1 hour each the participants cardiac output non-invasively assessed will be measured throughout the whole intervention
Randomly assigned to the order of testing the participants will be tested under simulated altitude FiO2 151 with the AMC Altitrainer and shamed altitude with the same device
During the exposure to simulated altitude FiO2 151 and shamed altitude of 1 hour each the participants cardiac output non-invasively assessed will be measured throughout the whole intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None