Exercise Performance on Ambient Air vs. Low-Flow Liquid Oxygen Therapy in Chronic Lung Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSilvia Ulrich Somaini

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 6-minute walk distance (6MWD) test on ambient conditions

    Other intervention

    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 intervention

    6-minute walk test(6MWT) test will be performed according to clinical standards with supplemental liquid oxygen therapy (LOX, approximately 4l/min, nasal)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Ambient airExperimental treatment 1 intervention
Group B: Liquid oxygen therapy via nasal canulaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air

Change in 6MWD in meter between supplemental liquid oxygen therapy (LOX) via nasal cannula vs. ambient air

Time frame
Distance will be measured at the end of 6 minutes from the 6MWT

Secondary outcomes

1

SpO2 at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with LOX approximately 4l /min vs. ambient air

Time frame
6 minutes
2

Heart rate at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

Change of heart rate (bpm) at rest and at peak 6MWD with LOX vs. ambient air

Time frame
6 minutes
3

Borg dyspnea at rest and peak 6MWT with supplemental liquid oxygen therapy (LOX) s. ambient air

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

Time frame
after 6 minutes
4

Borg leg fatigue scale at rest and peak 6MWD with supplemental liquid oxygen therapy (LOX) vs. ambient air

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

Time frame
6 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Silvia Ulrich Somaini

Lead sponsor

University of Zurich

Sponsor institution