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

Last updated: June 10, 2024
Sponsor: Skane University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Failure

Lung Disease

Lung Injury

Treatment

Added high-flow oxygen therapy

Standard care

Clinical Study ID

NCT06247397
HILOT
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 40 years or older

  • Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 daysas 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

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-relatedhypoventilation 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)

Study Design

Total Participants: 310
Treatment Group(s): 2
Primary Treatment: Added high-flow oxygen therapy
Phase:
Study Start date:
June 10, 2024
Estimated Completion Date:
December 31, 2028

Study Description

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.

Connect with a study center

  • Research Unit, Blekinge University of Technology

    Karlskrona, Blekinge 37185
    Sweden

    Active - Recruiting

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

    Örebro, 70185
    Sweden

    Active - Recruiting

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