Effect of HIgh-flow Therapy in Long-term Oxygen Therapy

Skane University Hospital310 enrolled

Overview

This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year. The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

310

Conditions

Chronic Obstructive Pulmonary Disease Severe Interstitial Lung Disease Chronic Respiratory Failure With Hypoxia

Interventions

Added high-flow oxygen therapyDEVICE

Added high-flow oxygen therapy using the device Lumis HFT during nighttime and at the patient's discretion daytime, with the usual care (low-flow oxygen therapy) the rest of the time.

Standard careOTHER

Standard care with low-flow oxygen therapy in accordance with clinical routine.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 40 years or older * Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox * COPD or ILD as main underlying reason for LTOT * Oxygen concentrator as stationary oxygen source in the home including night-time * Body mass index (BMI) \< 35 kg/m2 Exclusion Criteria: * Current or previous treatment with home HFOT * Current treatment with home mechanical ventilation * Current treatment with home CPAP * Hospitalized during the last 2 weeks * Current smoking or contact with flames * Self-reported average use of the LTOT \< 15h per day (24 hours) * PaCO2 (breathing air at rest) \> 8 kPa * Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff) * Inability to participate in the study procedures (as judged by the staff) * Not eligible for continuing LTOT due to other reason (as judged by the staff) * Expected survival less than 3 months (as judged by the staff)

Locations (2)

Research Unit, Blekinge University of Technology

Karlskrona, Blekinge County, Sweden

RECRUITING

Department of Heart, Lung and Clinical Physiology, Örebro University Hospital

Örebro, Sweden

RECRUITING

Outcomes

Primary Outcomes

Time to first hospitalization or death from all causes

Time to first hospitalization or death from all causes during 1 year after randomization in people with COPD (assessed using nationwide registry data)

Time frame: 1 year

Secondary Outcomes

Time to first all-cause hospitalization or all-cause death

Time to first all-cause hospitalization or all-cause death in people with ILD (assessed using nationwide registry data)

Time frame: 1 year

Rate of hospitalizations or death from all causes

Rate of hospitalizations or death from all causes assessed using nationwide registry data

Time frame: 1 year

Hospitalization rate from all causes

Hospitalization rate from all causes assessed using nationwide registry data

Time frame: 1 year

Hospitalization rate from respiratory disease

Hospitalization rate from respiratory disease assessed using nationwide registry data

Time frame: 1 year

Number of hospitalized days

Number of hospitalized days from all-causes, respiratory and cardiovascular disease using nationwide registry data

Time frame: 1 year

Hospitalization rate from cardiovascular disease

Hospitalization rate from cardiovascular disease assessed using nationwide registry data

Time frame: 1 year

Number of admissions to intensive care unit (ICU)

Central Contacts

Magnus Ekström, MD, PhD

CONTACT

0455731000 magnus.ekstrom@med.lu.se

Data from ClinicalTrials.gov

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