A Phase II Trial to Assess Feasibility of Using Nasal Cannula High Flow Therapy for Breathlessness in Participants with Chronic Obstructive Pulmonary Disease who do not qualify for domiciliary long-term oxygen therapy.

Not Applicable

Completed

• Conditions: chronic obstructive pulmonary disease; chronic breathlessness; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12621000044820
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Study Completion: 2022-12-14
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Underlying diagnosis of severe COPD – evidence on pulmonary function tests performed within the last 24 months of Forced Expiratory Ratio (FER) <70% and Forced Expiratory Volume 1sec (FEV1) <50%
•Physician confirmed optimisation of treatment of underlying disease
•Breathlessness scale: Level 3 or above on the modified Medical Research Council (mMRC) dyspnoea scale (Bausewein, et al., 2007)
•Not currently using domiciliary long-term oxygen therapy at rest via a concentrator for 16 hours/day (oxygen saturations > 92% at rest). However patients who only use exertional oxygen therapy from portable oxygen cylinders for exertion induced hypoxaemia are eligible
•Able and willing to provide written informed consent
•Capable of completing assessments and complying with the study procedures

Exclusion Criteria

•Acute exacerbations of COPD in the past four weeks (i.e. unstable disease)
•Enrolment in other clinical trials that may impact study outcomes (e.g. trials on breathlessness, opioids, benzodiazepines)
•Commenced on opioids or benzodiazepines within the last 14 days or requiring commencement of these medications while on study. Patients who were commenced on slow or immediate release opioids or benzodiazepines >14 days prior to study enrolment may continue to use these while on study.
•Previous adverse reaction to NHF
•Clinician predicted survival less than seven days
•Pregnant or breastfeeding
•Chronic alcoholism or drug abuse
•Contraindications to NHF use:
oRequiring Non-Invasive or Invasive ventilation
oAltered level of consciousness (GCS 10 or below)
oSuspected or known base of skull fracture
oInability to maintain own airway or unable to tolerate nasal prongs
oRecent surgery (in last 30 days) to the nose or upper airway - including pituitary surgery via a trans sphenoidal approach
oSignificant facial fractures or trauma in last 30 days
oNasal obstruction or nasal packing

Study & Design

• Study Type: Interventional
• Study Design: Not specified