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Background <p>The use of high-flow oxygen therapy (HFOT) compared with standard low-flow oxygen therapy (LFOT) may improve outcomes in people with oxygen-dependent chronic respiratory failure (CRF). The primary aim of this multicentre trial was to evaluate HFOT in addition to LFOT, compared with regular LFOT in people with CRF due to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).</p> Methods <p>Registry-based randomised controlled trial (R-RCT) of people on LFOT for CRF due to COPD (<i>n</i> = 270) and ILD (<i>n</i> = 40), at ten Swedish secondary care centres within the Swedish Register for Respiratory Failure (Swedevox). People with ongoing LFOT are randomised in a 1:1 ratio to standard treatment with LFOT (control) or LFOT with added HFOT during nighttime and at the patient’s discretion daytime (intervention). HFOT is provided using the ResMed Lumis HFT system and the AcuCare HFNC Cannula. Primary outcome is time to first hospitalisation or death up to 1 year in people with COPD. Secondary outcomes include symptoms, health-related outcomes (HRQL), health-economics, adverse events, and to explore the effects of HFOT in people with CRF due to ILD. Outcome data will be obtained from national registries and from patient questionnaires at 3 and 12&#xa0;months.</p> Discussion <p>This R-RCT will combine the advantages of a prospective randomised trial and large clinical national registries to improve the evidence-based use of long-term oxygen therapy. Recruitment started in June 2024 and is ongoing.</p> Trial registration <p>ClinicalTrials.gov, ID: NCT06247397. Registered 2024–02–07. </p>

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Effect of HIgh-Flow Therapy in Long-Term Oxygen Therapy (HILOT): study protocol for a multicentre, registry-based, randomised clinical trial

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  • 发表日期：

    2026年2月4日

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  • Josefin Sundh,
  • Mirjam Ljunggren,
  • Andreas Palm,
  • Eva Lindberg,
  • Florent Lavergne,
  • Ulla Møller Weinreich,
  • Zainab Ahmadi,
  • Magnus Ekström,
  • Anders Blomberg,
  • Pia Ghosh,
  • Taivo Kipper,
  • Ozran Kricka,
  • Bo Pedersen,
  • Anders Andersson,
  • Jonas Einarsson,
  • Hanan Tanash

摘要

Background

The use of high-flow oxygen therapy (HFOT) compared with standard low-flow oxygen therapy (LFOT) may improve outcomes in people with oxygen-dependent chronic respiratory failure (CRF). The primary aim of this multicentre trial was to evaluate HFOT in addition to LFOT, compared with regular LFOT in people with CRF due to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

Methods

Registry-based randomised controlled trial (R-RCT) of people on LFOT for CRF due to COPD (n = 270) and ILD (n = 40), at ten Swedish secondary care centres within the Swedish Register for Respiratory Failure (Swedevox). People with ongoing LFOT are randomised in a 1:1 ratio to standard treatment with LFOT (control) or LFOT with added HFOT during nighttime and at the patient’s discretion daytime (intervention). HFOT is provided using the ResMed Lumis HFT system and the AcuCare HFNC Cannula. Primary outcome is time to first hospitalisation or death up to 1 year in people with COPD. Secondary outcomes include symptoms, health-related outcomes (HRQL), health-economics, adverse events, and to explore the effects of HFOT in people with CRF due to ILD. Outcome data will be obtained from national registries and from patient questionnaires at 3 and 12 months.

Discussion

This R-RCT will combine the advantages of a prospective randomised trial and large clinical national registries to improve the evidence-based use of long-term oxygen therapy. Recruitment started in June 2024 and is ongoing.

Trial registration

ClinicalTrials.gov, ID: NCT06247397. Registered 2024–02–07.