Effect of Short-term Oxygen During CPET in ILD

Not Applicable

Not yet recruiting

• Conditions: Interstitial Lung Disease
• Interventions: Procedure: Incremental exercise test (IET); Procedure: Constant work rate exercise test (CWRET)

• Registration Number: NCT04897048
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Study Start: 2023-07-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Air	Constant work rate exercise test (CWRET)	Sham ambient air will be applied via mask during CPET
Oxygen	Incremental exercise test (IET)	Supplemental oxygen will be applied via a mask during CPET
Oxygen	Constant work rate exercise test (CWRET)	Supplemental oxygen will be applied via a mask during CPET
Air	Incremental exercise test (IET)	Sham ambient air will be applied via mask during CPET

Primary Outcome Measures

Name	Time	Method
Work Rate (in watts)	1 day	Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Endurance time (in seconds)	1 day	Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests

Secondary Outcome Measures

Name	Time	Method
Changes in arterial blood: Bicarbonate (HCO3)	1 day	HCO3 (in mmol per liter)
Changes in breathing patterns: Oxygen uptake (VO2)	1 day	VO2 (in liters per minute)
Changes in arterial blood: pondus Hydrogenii (pH) values	1 day	pH (1-14)
changes in physiological vital signs: Heart rate (hr)	1 day	Hr (in beats per minute)
Changes in breathing patterns: Carbon dioxide output (VCO2)	1 day	VCO2 (in liters per minute)
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)	1 day	ratio between minute ventilation and oxygen uptake
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)	1 day	ratio between minute ventilation and carbon dioxide output
Changes in breathing patterns: VE/VCO2Slope	1 day	Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau
Changes in breathing patterns: Ventilatory threshold one (Vt1)	1 day	represents the start of anaerobic metabolism
Changes in breathing patterns: Minute ventilation (VE)	1 day	VE (in liters per minute)
Changes breathing patterns: Tidal volume (Vt)	1 day	Vt (in liters)
changes in physiological vital signs: Blood pressure	1 day	Systolic and diastolic blood pressure (in mmHg)
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)	1 day	PaCO2 (in kPa)
Changes in breathing patterns: Ventilatory threshold two (Vt2)	1 day	represents the start of higher percentage of the anaerobic metabolism
Changes in arterial blood: arterial partial pressure of O2 (PaO2)	1 day	PaO2 (in kPa)
Changes in arterial blood: arterial lactate concentration	1 day	lactate concentration (in mmol per liter)
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)	1 day	CTO (in percent)
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)	1 day	SpO2 (in percent)
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)	1 day	MTO (in percent)

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland