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Exercise Performance on Ambient Air vs. Low-Flow Liquid Oxygen Therapy in Pulmonary Vascular Disease (PVD)

NCT07777445 — Not applicable, Recruiting, 40 participants, Silvia Ulrich Somaini

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Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Flow Oxygen Therapy in Patients With Exercise Induced Desaturation Due to Pulmonary Disease

RegistryNCT07777445
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none, other
Enrollment40 (Estimated)
SponsorSilvia Ulrich Somaini (Other)
ConditionsPulmonary Vascular Disease, Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH)
Interventions6-minute walk distance (6MWD) test on ambient conditions, 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) (Other)
Datesstart 2026-10-01 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-08-20, last updated 2026-09-09
Locations1 site in Switzerland

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-Summary

The investigators aim to study the effect of liquid oxygen therapy (4l/min, nasal) )in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

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+Detailed description

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without nasal liquid oxygen therapy (LOX) approximately 4l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with LOX is inferior to a 6MWD in the same participant under ambient air.

+Arms and interventions

ArmTypeInterventionsDescription
Ambient airExperimentalOther: 6-minute walk distance (6MWD) test on ambient conditionsPatient will be assessed at University Hospital Zurich
Liquid oxygen therapy via nasal canulaActive comparatorOther: 6-minute walk distance (6MWD) test with supplemental oxygen (LOX)Supplemental Liquid Oxygen Therapy (LOX) at approximately 4l/min will be provided via nasal canula from a small oxygen tank at University Hospital Zurich to perform clinical assessments.
  • 6-minute walk distance (6MWD) test on ambient conditions (Other): 6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
  • 6-minute walk distance (6MWD) test with supplemental oxygen (LOX) (Other): 6-minute walk test(6MWT) test will be performed according to clinical standards with supplemental liquid oxygen therapy (LOX, approximately 4l/min, nasal)

+Outcome measures

Primary outcomes

  • 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air [Distance will be measured at the end of 6 minutes from the 6MWT]: Change in 6MWD in meter between supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air

Secondary outcomes

  • SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air [6 minutes]: Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with LOX approximately 4l /min vs. ambient air
  • Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air [6 minutes]: Change of heart rate (bpm) at rest and at peak 6MWD with LOX vs. ambient air
  • Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air [6 minutes]: Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with LOX vs. ambient air
  • Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air [6 minutes]: Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWT with LOX vs. ambient air
  • Blood pressure at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air [6 minutes]: Change of blood pressure (mmHg) at rest and at peak 6MWD with LOX vs. ambient air

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* \- Minimum 18 years of age
* Written informed consent
* Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH), chronic obstructive pulmonary disease (COPD) with emphysema, COPD without emphysema, or interstitial lung disease
* Former desaturation under exercise defined as SpO2-decrease >3%
* Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria:

* \- Severe hypoxemia needing supplemental oxygen therapy defined as PaO2 < 6.9 kPa
* Inability or contraindications to undergo the investigated intervention
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, walk disability etc.

+Locations (1)

FacilityCityCountryStatus
University Hospital ZurichZurich, Canton of ZurichSwitzerlandRecruiting

+Investigators

My Notes