Clinical trial NCT04897048: Effect of Short-term Oxygen During CPET in ILD
Official title: Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 interstitial lung disease.


Eligibility criteria: Inclusion Criteria:

* interstitial lung disease, diagnosed by high-resolution CT
* FEV1/FVC \>70% and FVC \<85% predicted
* stable medication for at least 4 weeks
* Desaturation in SpO2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92%
* Signed Informed Consent
* Male and female patients 18 to 80 years of age

Exclusion Criteria:

* Severe daytime hypoxemia (PaO2 ≤7.3 or \<55 mmHg at rest)
* Other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic problems with walking disability or inability to ride a bicycle
* Women who are pregnant or breast feeding

Primary outcomes:
measure: Work Rate (in watts)
timeFrame: 1 day
measure: Endurance time (in seconds)
timeFrame: 1 day
Secondary outcomes:
measure: changes in physiological vital signs: Heart rate (hr)
timeFrame: 1 day
measure: changes in physiological vital signs: Blood pressure
timeFrame: 1 day
measure: Changes in breathing patterns: Minute ventilation (VE)
timeFrame: 1 day
measure: Changes breathing patterns: Tidal volume (Vt)
timeFrame: 1 day
measure: Changes in breathing patterns: Oxygen uptake (VO2)
timeFrame: 1 day
measure: Changes in breathing patterns: Carbon dioxide output (VCO2)
timeFrame: 1 day
measure: Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)
timeFrame: 1 day
measure: Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)
timeFrame: 1 day
measure: Changes in breathing patterns: VE/VCO2Slope
timeFrame: 1 day
measure: Changes in breathing patterns: Ventilatory threshold one (Vt1)
timeFrame: 1 day
measure: Changes in breathing patterns: Ventilatory threshold two (Vt2)
timeFrame: 1 day
measure: Changes in arterial blood: arterial partial pressure of O2 (PaO2)
timeFrame: 1 day
measure: Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)
timeFrame: 1 day
measure: Changes in arterial blood: arterial lactate concentration
timeFrame: 1 day
measure: Changes in arterial blood: pondus Hydrogenii (pH) values
timeFrame: 1 day
measure: Changes in arterial blood: Bicarbonate (HCO3)
timeFrame: 1 day
measure: Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)
timeFrame: 1 day
measure: Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)
timeFrame: 1 day
measure: Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)
timeFrame: 1 day
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
References: