University Hospital Zurich, Division of Pneumology
Zurich, , 8091, Switzerland
Completed
NCT Number: NCT04076501
Effect of Short-term Oxygen During CPET in GUCH
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with grown-up congenital heart disease.
Completed
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- GUCH, stable medication for at least 4 weeks.
Exclusion criteria
- instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
Treatment and study plan
Oxygen application
ProcedureOxygen application Supplemental oxygen via mask
Sham room air
ProcedureRoom air applied via mask
Primary outcomes
-
Work Rate (Watt)
Time frame: 1 day
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
-
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Time frame: 1 day
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Secondary outcomes
-
Peak Oxygen uptake
Time frame: 1 day
measured during cardiopulmonary exercise test oxygen vs. room air
-
Respiratory Exchange ratio
Time frame: 1 day
measured during cardiopulmonary exercise test oxygen vs. room air
-
Changes in arterial blood parameters
Time frame: 1 day
measured during cardiopulmonary exercise test oxygen vs. room air
-
muscle tissue oxygen
Time frame: 1 day
Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
-
cerebral tissue oxygen
Time frame: 1 day
Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
Sponsors and collaborators
Lead sponsor
University of Zurich
Other
Registry information
Official study title
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)
Important dates
- Study start
- 2019
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Sep 3, 2019
- Registry last updated
- Apr 19, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.