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Not yet recruitingNCT07891208Updated Oct 23, 2026

Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia

An interventional study of Nasal high flow oxygen in Nasal High Flow Oxygen Therapy Effect on Lower Limb Ischaemia, sponsored by Fisher and Paykel Healthcare. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Supportive care

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasal High Flow Oxygen Therapy Effect on Lower Limb Ischaemia
03

In context

Lead sponsor

Fisher and Paykel Healthcare is the lead sponsor of 86 studies on the registry; 16 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Documented CO2 retention.
  • Use of Bleomycin within the last 6-months.
  • Pneumothorax.
  • Craniofacial trauma or surgery.
  • Nasal obstruction.
  • Nasal trauma
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Nasal high flow oxygen

    Device: Nasal high flow oxygen

Interventions

  • DeviceNasal high flow oxygen

    Normobaric nasal high flow oxygen for lower limb ischaemia

06

What researchers measure

Primary outcomes

  1. Effect on rest and/or wound pain score

    Does elevated FiO2 affect rest or wound pain score assessed with 11 point verbal numerical rating scale (vNRS-11)

    Time frame: End of treatment on day 5

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07891208
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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