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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

Sundh, Josefin ; Ljunggren, Mirjam ; Palm, Andreas ; Lindberg, Eva ; Lavergne, Florent ; Weinreich, Ulla Møller ; Ahmadi, Zainab LU ; Ekström, Magnus LU orcid ; Tanash, Hanan LU and Einarsson, Jonas LU orcid , et al. (2026) In Trials 27(1).
Abstract

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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Adverse events, Chronic obstructive pulmonary disease, Exacerbations, High-flow oxygen therapy, Hospitalisations, Interstitial lung disease, Long-term oxygen therapy, Low-flow oxygen therapy, Mortality, Symptoms
in
Trials
volume
27
issue
1
article number
177
publisher
BioMed Central (BMC)
external identifiers
  • pmid:41634827
  • scopus:105030993340
ISSN
1745-6215
DOI
10.1186/s13063-026-09488-8
language
English
LU publication?
yes
additional info
Publisher Copyright: © The Author(s) 2026.
id
a61f52cb-119e-4c64-b9be-fc84eb87da61
date added to LUP
2026-04-21 15:21:02
date last changed
2026-05-19 17:07:50
@article{a61f52cb-119e-4c64-b9be-fc84eb87da61,
  abstract     = {{<p>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.</p>}},
  author       = {{Sundh, Josefin and Ljunggren, Mirjam and Palm, Andreas and Lindberg, Eva and Lavergne, Florent and Weinreich, Ulla Møller and Ahmadi, Zainab and Ekström, Magnus and Tanash, Hanan and Einarsson, Jonas and Andersson, Anders and Pedersen, Bo and Kricka, Ozran and Kipper, Taivo and Ghosh, Pia and Blomberg, Anders}},
  issn         = {{1745-6215}},
  keywords     = {{Adverse events; Chronic obstructive pulmonary disease; Exacerbations; High-flow oxygen therapy; Hospitalisations; Interstitial lung disease; Long-term oxygen therapy; Low-flow oxygen therapy; Mortality; Symptoms}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Effect of HIgh-Flow Therapy in Long-Term Oxygen Therapy (HILOT) : study protocol for a multicentre, registry-based, randomised clinical trial}},
  url          = {{http://dx.doi.org/10.1186/s13063-026-09488-8}},
  doi          = {{10.1186/s13063-026-09488-8}},
  volume       = {{27}},
  year         = {{2026}},
}