Effect of Short-term Oxygen During CPET in ILD

Interstitial Lung Disease Clinical Trial

Official title:

Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04897048
• Other study ID #: KEK-ZH-NR. 2012-0251_5
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: Silvia Ulrich, Prof. Dr.
• Phone: +41442552220
• Email: silvia.ulrich[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Incremental exercise test (IET)
Incremental cardio pulmonary exercise test until exhaustion
• Constant work rate exercise test (CWRET)
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

Locations

Country	Name	City	State
Switzerland	Respiratory Clinic, University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Rate (in watts)	Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests	1 day
Primary	Endurance time (in seconds)	Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests	1 day
Secondary	changes in physiological vital signs: Heart rate (hr)	Hr (in beats per minute)	1 day
Secondary	changes in physiological vital signs: Blood pressure	Systolic and diastolic blood pressure (in mmHg)	1 day
Secondary	Changes in breathing patterns: Minute ventilation (VE)	VE (in liters per minute)	1 day
Secondary	Changes breathing patterns: Tidal volume (Vt)	Vt (in liters)	1 day
Secondary	Changes in breathing patterns: Oxygen uptake (VO2)	VO2 (in liters per minute)	1 day
Secondary	Changes in breathing patterns: Carbon dioxide output (VCO2)	VCO2 (in liters per minute)	1 day
Secondary	Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)	ratio between minute ventilation and oxygen uptake	1 day
Secondary	Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)	ratio between minute ventilation and carbon dioxide output	1 day
Secondary	Changes in breathing patterns: VE/VCO2Slope	Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau	1 day
Secondary	Changes in breathing patterns: Ventilatory threshold one (Vt1)	represents the start of anaerobic metabolism	1 day
Secondary	Changes in breathing patterns: Ventilatory threshold two (Vt2)	represents the start of higher percentage of the anaerobic metabolism	1 day
Secondary	Changes in arterial blood: arterial partial pressure of O2 (PaO2)	PaO2 (in kPa)	1 day
Secondary	Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)	PaCO2 (in kPa)	1 day
Secondary	Changes in arterial blood: arterial lactate concentration	lactate concentration (in mmol per liter)	1 day
Secondary	Changes in arterial blood: pondus Hydrogenii (pH) values	pH (1-14)	1 day
Secondary	Changes in arterial blood: Bicarbonate (HCO3)	HCO3 (in mmol per liter)	1 day
Secondary	Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)	SpO2 (in percent)	1 day
Secondary	Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)	CTO (in percent)	1 day
Secondary	Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)	MTO (in percent)	1 day