Effect of Short-term Oxygen During CPET in ILD

November 1, 2022 updated by: University of Zurich

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Respiratory Clinic, University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oxygen
Supplemental oxygen will be applied via a mask during CPET
Procedure: Incremental exercise test (IET)
Incremental cardio pulmonary exercise test until exhaustion
Procedure: Constant work rate exercise test (CWRET)
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
Sham Comparator: Air
Sham ambient air will be applied via mask during CPET
Procedure: Incremental exercise test (IET)
Incremental cardio pulmonary exercise test until exhaustion
Procedure: Constant work rate exercise test (CWRET)
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Work Rate (in watts)
Time Frame: 1 day
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
1 day
Endurance time (in seconds)
Time Frame: 1 day
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in physiological vital signs: Heart rate (hr)
Time Frame: 1 day
Hr (in beats per minute)
1 day
changes in physiological vital signs: Blood pressure
Time Frame: 1 day
Systolic and diastolic blood pressure (in mmHg)
1 day
Changes in breathing patterns: Minute ventilation (VE)
Time Frame: 1 day
VE (in liters per minute)
1 day
Changes breathing patterns: Tidal volume (Vt)
Time Frame: 1 day
Vt (in liters)
1 day
Changes in breathing patterns: Oxygen uptake (VO2)
Time Frame: 1 day
VO2 (in liters per minute)
1 day
Changes in breathing patterns: Carbon dioxide output (VCO2)
Time Frame: 1 day
VCO2 (in liters per minute)
1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)
Time Frame: 1 day
ratio between minute ventilation and oxygen uptake
1 day
Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)
Time Frame: 1 day
ratio between minute ventilation and carbon dioxide output
1 day
Changes in breathing patterns: VE/VCO2Slope
Time Frame: 1 day
Ratio between minute ventilation and carbon dioxide output if carbon dioxide reaches the breathing plateau
1 day
Changes in breathing patterns: Ventilatory threshold one (Vt1)
Time Frame: 1 day
represents the start of anaerobic metabolism
1 day
Changes in breathing patterns: Ventilatory threshold two (Vt2)
Time Frame: 1 day
represents the start of higher percentage of the anaerobic metabolism
1 day
Changes in arterial blood: arterial partial pressure of O2 (PaO2)
Time Frame: 1 day
PaO2 (in kPa)
1 day
Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)
Time Frame: 1 day
PaCO2 (in kPa)
1 day
Changes in arterial blood: arterial lactate concentration
Time Frame: 1 day
lactate concentration (in mmol per liter)
1 day
Changes in arterial blood: pondus Hydrogenii (pH) values
Time Frame: 1 day
pH (1-14)
1 day
Changes in arterial blood: Bicarbonate (HCO3)
Time Frame: 1 day
HCO3 (in mmol per liter)
1 day
Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)
Time Frame: 1 day
SpO2 (in percent)
1 day
Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)
Time Frame: 1 day
CTO (in percent)
1 day
Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)
Time Frame: 1 day
MTO (in percent)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KEK-ZH-NR. 2012-0251_5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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