Acute Effects of Oxygen Supplementation Among IPF Patients
Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia
Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.
Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Thessaloniki, Greece, 57010
- "G. Papanikolaou" General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month
- IPF patients do not present with resting hypoxemia, but manifest exercise induced hypoxemia
Exclusion Criteria:
- Major contraindications for CPET conduction
- Not provision of informed consent -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: IPF patients
Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing
|
Oxygen supplementation (40%) via Venturi mask
|
|
Sham Comparator: IPF patients (crossover)
Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing
|
Medical air supplementation via Venturi mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise duration
Time Frame: through study completion, an average of a year
|
Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion
|
through study completion, an average of a year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea
Time Frame: through study completion, an average of a year
|
maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing
|
through study completion, an average of a year
|
|
Fatigue
Time Frame: through study completion, an average of a year
|
maximum fatigue assessed by Borg's Rating of Perceived Exertion Scale (range from 6: no exertion to 20: maximal exertion), during steady state cardiopulmonary exercise testing
|
through study completion, an average of a year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral oxygenated hemoglobin
Time Frame: through study completion, an average of a year
|
The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
|
through study completion, an average of a year
|
|
Cardiac output
Time Frame: through study completion, an average of a year
|
The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing
|
through study completion, an average of a year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Aikaterini Markopoulou, MD, PhD, "G. Papanikolaou" General Hospital, Thessaloniki, Greece
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 804/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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