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

Silvia Ulrich Somaini40 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pulmonary Vascular Disease Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Pulmonary Arterial Hypertension (PAH)

Interventions

6-minute walk distance (6MWD) test on ambient conditionsOTHER

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

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

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

Change of blood pressure (mmHg) at rest and at peak 6MWD with LOX vs. ambient air

Time frame: 6 minutes

Central Contacts

Silvia Ulrich, Prof. Dr. med.

CONTACT

+41442552220 silvia.ulrich@usz.ch

Mona Lichtblau, PD. Dr. med.

CONTACT

+41442552220 mona.lichtblau@usz.ch

Data from ClinicalTrials.gov

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