Back to resultsEffect of Short-term Oxygen During CPET in ILD
Primary Purpose
Interstitial Lung Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Incremental exercise test (IET)
Constant work rate exercise test (CWRET)
Sponsored by
About this trial
This is an interventional supportive care trial for 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
Sites / Locations
- Respiratory Clinic, University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Oxygen
Air
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Sham ambient air will be applied via mask during CPET
Outcomes
Primary Outcome Measures
Work Rate (in watts)
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Endurance time (in seconds)
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
Secondary Outcome Measures
changes in physiological vital signs: Heart rate (hr)
Hr (in beats per minute)
changes in physiological vital signs: Blood pressure
Systolic and diastolic blood pressure (in mmHg)
Changes in breathing patterns: Minute ventilation (VE)
VE (in liters per minute)
Changes breathing patterns: Tidal volume (Vt)
Vt (in liters)
Changes in breathing patterns: Oxygen uptake (VO2)
VO2 (in liters per minute)
Changes in breathing patterns: Carbon dioxide output (VCO2)
VCO2 (in liters per minute)
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)
ratio between minute ventilation and oxygen uptake
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)
ratio between minute ventilation and carbon dioxide output
Changes in breathing patterns: VE/VCO2Slope
Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau
Changes in breathing patterns: Ventilatory threshold one (Vt1)
represents the start of anaerobic metabolism
Changes in breathing patterns: Ventilatory threshold two (Vt2)
represents the start of higher percentage of the anaerobic metabolism
Changes in arterial blood: arterial partial pressure of O2 (PaO2)
PaO2 (in kPa)
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)
PaCO2 (in kPa)
Changes in arterial blood: arterial lactate concentration
lactate concentration (in mmol per liter)
Changes in arterial blood: pondus Hydrogenii (pH) values
pH (1-14)
Changes in arterial blood: Bicarbonate (HCO3)
HCO3 (in mmol per liter)
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)
SpO2 (in percent)
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)
CTO (in percent)
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)
MTO (in percent)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04897048
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxygen
Arm Type
Experimental
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Arm Title
Air
Arm Type
Sham Comparator
Arm Description
Sham ambient air will be applied via mask during CPET
Intervention Type
Procedure
Intervention Name(s)
Incremental exercise test (IET)
Intervention Description
Incremental cardio pulmonary exercise test until exhaustion
Intervention Type
Procedure
Intervention Name(s)
Constant work rate exercise test (CWRET)
Intervention Description
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
Primary Outcome Measure Information:
Title
Work Rate (in watts)
Description
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Time Frame
1 day
Title
Endurance time (in seconds)
Description
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
Time Frame
1 day
Secondary Outcome Measure Information:
Title
changes in physiological vital signs: Heart rate (hr)
Description
Hr (in beats per minute)
Time Frame
1 day
Title
changes in physiological vital signs: Blood pressure
Description
Systolic and diastolic blood pressure (in mmHg)
Time Frame
1 day
Title
Changes in breathing patterns: Minute ventilation (VE)
Description
VE (in liters per minute)
Time Frame
1 day
Title
Changes breathing patterns: Tidal volume (Vt)
Description
Vt (in liters)
Time Frame
1 day
Title
Changes in breathing patterns: Oxygen uptake (VO2)
Description
VO2 (in liters per minute)
Time Frame
1 day
Title
Changes in breathing patterns: Carbon dioxide output (VCO2)
Description
VCO2 (in liters per minute)
Time Frame
1 day
Title
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)
Description
ratio between minute ventilation and oxygen uptake
Time Frame
1 day
Title
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)
Description
ratio between minute ventilation and carbon dioxide output
Time Frame
1 day
Title
Changes in breathing patterns: VE/VCO2Slope
Description
Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau
Time Frame
1 day
Title
Changes in breathing patterns: Ventilatory threshold one (Vt1)
Description
represents the start of anaerobic metabolism
Time Frame
1 day
Title
Changes in breathing patterns: Ventilatory threshold two (Vt2)
Description
represents the start of higher percentage of the anaerobic metabolism
Time Frame
1 day
Title
Changes in arterial blood: arterial partial pressure of O2 (PaO2)
Description
PaO2 (in kPa)
Time Frame
1 day
Title
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)
Description
PaCO2 (in kPa)
Time Frame
1 day
Title
Changes in arterial blood: arterial lactate concentration
Description
lactate concentration (in mmol per liter)
Time Frame
1 day
Title
Changes in arterial blood: pondus Hydrogenii (pH) values
Description
pH (1-14)
Time Frame
1 day
Title
Changes in arterial blood: Bicarbonate (HCO3)
Description
HCO3 (in mmol per liter)
Time Frame
1 day
Title
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)
Description
SpO2 (in percent)
Time Frame
1 day
Title
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)
Description
CTO (in percent)
Time Frame
1 day
Title
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)
Description
MTO (in percent)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Ulrich, Prof. Dr.
Phone
+41442552220
Email
silvia.ulrich@usz.ch
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Short-term Oxygen During CPET in ILD
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