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Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia

A Prospective Pilot Efficacy Study of Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07891208
Enrollment
40
Registered
2026-10-23
Start date
2026-11-01
Completion date
2029-06-01
Last updated
2026-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Ischaemia

Brief summary

A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or wound related pain.

Interventions

DEVICENasal high flow oxygen

Normobaric nasal high flow oxygen for lower limb ischaemia

Sponsors

Fisher and Paykel Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with rest pain and or wound pain due to lower leg ischaemia, with or without an ulcer. * Aged 16 years and over. * Able to provide informed consent. * Able to attend 5 consecutive days for the study.

Exclusion criteria

* Documented CO2 retention. * Use of Bleomycin within the last 6-months. * Pneumothorax. * Craniofacial trauma or surgery. * Nasal obstruction. * Nasal trauma

Design outcomes

Primary

MeasureTime frameDescription
Effect on rest and/or wound pain scoreEnd of treatment on day 5Does elevated FiO2 affect rest or wound pain score assessed with 11 point verbal numerical rating scale (vNRS-11). Score range between 0 (no pain) and 10 (maximum pain).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 27, 2026