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Oxygen Treatment and Pulmonary Arterial Hypertension

Primary Purpose

Pulmonary Arterial Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Oxygen supplementation
Sham O2 (medical air)
Sponsored by
George Papanicolaou Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Group I PAH patients
  2. Stable disease (no hospitalisation, disease deterioration or change in regular PAH medication during the last month)
  3. Presence of exercise-induced hypoxemia

Exclusion Criteria:

  1. Major contraindications for CPET conduction
  2. Not providing informed consent -

Sites / Locations

  • "G. Papanikolaou" General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

PAH patients

PAH patients (crossover)

Arm Description

Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask

Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask

Outcomes

Primary Outcome Measures

Exercise duration
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion

Secondary Outcome Measures

Dyspnea
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
cerebral oxygenated hemoglobin
minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
Cardiac output
maximum cardiac output during steady state cardiopulmonary exercise testing
Fatigue
Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing

Full Information

First Posted
September 20, 2018
Last Updated
September 21, 2018
Sponsor
George Papanicolaou Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03683082
Brief Title
Oxygen Treatment and Pulmonary Arterial Hypertension
Official Title
Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Papanicolaou Hospital

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
Pulmonary arterial hypertension (PAH) 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 PAH, 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, crossover 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 PAH, during steady state cardiopulmonary exercise testing (CPET)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAH patients
Arm Type
Active Comparator
Arm Description
Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask
Arm Title
PAH patients (crossover)
Arm Type
Sham Comparator
Arm Description
Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask
Intervention Type
Drug
Intervention Name(s)
Oxygen supplementation
Intervention Description
40% FiO2 via Venturi mask
Intervention Type
Drug
Intervention Name(s)
Sham O2 (medical air)
Intervention Description
Medical air supplementation via Venturi mask
Primary Outcome Measure Information:
Title
Exercise duration
Description
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
Time Frame
through study completion, an average of a year
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
Time Frame
through study completion, an average of a year
Title
cerebral oxygenated hemoglobin
Description
minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
Time Frame
through study completion, an average of a year
Title
Cardiac output
Description
maximum cardiac output during steady state cardiopulmonary exercise testing
Time Frame
through study completion an average of a year
Title
Fatigue
Description
Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing
Time Frame
through study completion, an average of a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Group I PAH patients Stable disease (no hospitalisation, disease deterioration or change in regular PAH medication during the last month) Presence of exercise-induced hypoxemia Exclusion Criteria: Major contraindications for CPET conduction Not providing informed consent -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afroditi Boutou, MD, PhD, MSc
Phone
00306946611433
Email
afboutou@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia Pitsiou, MD, Ass Prof
Organizational Affiliation
"G. Papanikolaou" General Hospital, Thessaloniki, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
"G. Papanikolaou" General Hospital
City
Thessaloníki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afroditi Boutou, MD, MSc, PhD
Phone
00306946611433
Email
afboutou@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34274251
Citation
Dipla K, Boutou AK, Markopoulou A, Papadopoulos S, Kritikou S, Pitsiou G, Stanopoulos I, Kioumis I, Zafeiridis A. Differences in cerebral oxygenation during exercise in patients with idiopathic pulmonary fibrosis with and without exertional hypoxemia: does exercise intensity matter? Pulmonology. 2023 May-Jun;29(3):221-229. doi: 10.1016/j.pulmoe.2021.06.006. Epub 2021 Jul 15.
Results Reference
derived
PubMed Identifier
33957299
Citation
Boutou AK, Dipla K, Zafeiridis A, Markopoulou A, Papadopoulos S, Kritikou S, Panagiotidou E, Stanopoulos I, Pitsiou G. A randomized placebo-control trial of the acute effects of oxygen supplementation on exercise hemodynamics, autonomic modulation, and brain oxygenation in patients with pulmonary hypertension. Respir Physiol Neurobiol. 2021 Aug;290:103677. doi: 10.1016/j.resp.2021.103677. Epub 2021 May 3.
Results Reference
derived

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Oxygen Treatment and Pulmonary Arterial Hypertension

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