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High Flow in Interstitial Lung Disease

NCT03816722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-03

No results posted yet for this study

Summary

This is a prospective, 6 week cross-over study on the effect of High flow nasal cannula (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory oxygen therapy.

Primary outcome:

To investigate intra-personal differences in 6MWT, as well as SO2 and BORG score at the end of the 6MWT, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in SGRQ at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in quality of sleep, using the Richards-Campbell sleep questionnaire (RCSQ) at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in IC, at baseline, at 6 weeks and 12 weeks

Secondary outcome:

To investigate intra-personal differences in FVC, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in DLCO at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in mMRC-score at baseline, at 6 weeks and 12 weeks

Conditions

  • Lung Diseases, Interstitial

Interventions

DEVICE

Airvo2

Treatment with HighFlow through the Airvo2 device, 8 hours per day

OTHER

Usual care

High flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. "Usual care" will be unaltered a month before inclusion in the study in each of the individual patients

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Ulla M Weinreich, MD, PhD · Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2021-06-03
Completion
2021-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816722 on ClinicalTrials.gov