Clinical trial NCT03899558: The Role of HNHF to Improve Clinical Outcomes Following Severe AECOPD
Official title: The Role of Humidified Nasal High-flow to Reduce 30-day Hospital Re-admissions Following Severe Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed Methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Neural respiratory drive
Physiology
Respiratory muscles
COPD exacerbation
Ventilation
Nasal high-flow
High-flow nasal cannula
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing symptoms called acute exacerbations (AECOPD). Exacerbations occur more often as the disease progresses and are a leading cause of emergency hospitalisation. Patients recovering from exacerbations are at high risk of deteriorating, with one quarter readmitted to hospital within thirty days. COPD thus imposes immense burdens on the National Health Service and patients.

This research will investigate the effects of using humidified nasal high-flow (HNHF) during recovery from severe COPD exacerbations. HNHF delivers warmed, humidified air under flows of up to 60 litres per minute through a nasal interface. This has been shown to improve clinical outcomes, including exacerbation frequency, hospitalisations, breathlessness and quality of life amongst COPD patients with respiratory failure. It is thought to achieve this by improving secretion clearance and providing positive airways pressure which supports the breathing system.

Patients admitted to St Thomas' Hospital, London with COPD exacerbations will be recruited. Prior to discharge, participants will be randomised to receive either usual care alone or usual care plus a HNHF device, which they will be trained to use for a regular period daily. Usual care includes inhalers, steroids and may include antibiotics.

Participants will be followed up for 30-days after hospital discharge using weekly assessments, daily symptom diaries and wrist-worn watch-like devices that detect physical activity. This will enable evaluation of the clinical effects of HNHF on re-exacerbations, readmissions, breathlessness, physical activity and quality of life. Device usage will also be quantified. Participants who receive devices will be interviewed to explore their experiences. After the 30-day home follow-up period, a sub-group of participants will undergo detailed breathing tests during and after exercise to explore the effects of HNHF on the respiratory system.


Eligibility criteria: Inclusion Criteria:

* Emergency hospital admission with a primary diagnosis of AECOPD
* Aged 40-80 years
* ≥10 pack year smoking history
* Body mass index ≤ 35kg/m2
* Cognitively and linguistically able to follow English instructions, provide informed consent and complete the study protocol
* To be discharged home following the hospitalisation in a home environment deemed safe by the investigator to perform home assessments
* Patient lives in the catchment area served by the Integrated Respiratory Team at Guy's and St Thomas' NHS Foundation Trust

Exclusion Criteria:

* Chest radiograph excludes pneumothorax
* Requirement for acute non-invasive ventilation (NIV) during index hospitalisation or established on home positive airway pressure (PAP)
* Significant chronic respiratory failure (PaCO2 \>7.0)
* Clinically significant obstructive sleep apnoea requiring treatment
* Allergies to latex, metals or local anaesthetic
* Broken or inflamed skin at the second intercostal space parasternal chest wall areas
* Psychological or social factors that would impair compliance with the study protocol
* Any major non-COPD chronic co-morbidity that may contribute significantly to risk of readmission, including (but not limited to) severe heart failure (left ventricular ejection fraction \<30%), malignancy (active treatment or palliation), end stage renal failure and significant neuromuscular disease
* Planned travel away from home in the 30-day post-discharge period

Primary outcomes:
measure: Time to 30-day hospital readmission following index hospitalisation with AECOPD
timeFrame: 30 days following hospital discharge
Secondary outcomes:
measure: Recruitment rate of eligible patients
timeFrame: 30 days following hospital discharge
measure: Adherence with completion of clinical outcome measures (symptom diary)
timeFrame: 30 days following hospital discharge
measure: Adherence with completion of clinical outcome measures (physical activity monitor)
timeFrame: 30 days following hospital discharge
measure: Adherence with completion of clinical outcome measures (spirometry)
timeFrame: 30 days following hospital discharge
measure: Participants' HNHF device usage
timeFrame: 30 days following hospital discharge
measure: Acceptability of HNHF at home: semi-structured interviews
timeFrame: 30 days following hospital discharge
measure: Non-readmission AECOPD
timeFrame: 30 days following hospital discharge
measure: Breathlessness
timeFrame: 30 days following hospital discharge
measure: Breathlessness
timeFrame: 30 days following hospital discharge
measure: Physical activity
timeFrame: 30 days following hospital discharge
measure: Health-related quality of life: COPD Assessment Test
timeFrame: 30 days following hospital discharge
measure: Health-related quality of life: Clinical COPD Questionnaire
timeFrame: 30 days following hospital discharge
measure: Inspiratory capacity
timeFrame: 30 days following hospital discharge
measure: Breathlessness
timeFrame: 30 days following hospital discharge
measure: Neural respiratory drive
timeFrame: 30 days following hospital discharge
measure: Pulmonary pressures and flow
timeFrame: 30 days following hospital discharge
measure: Time to recover from maximal breathlessness
timeFrame: 30 days following hospital discharge
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Nicholas Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suh ES, Mandal S, Harding R, Ramsay M, Kamalanathan M, Henderson K, O'Kane K, Douiri A, Hopkinson NS, Polkey MI, Rafferty G, Murphy PB, Moxham J, Hart N. Neural respiratory drive predicts clinical deterioration and safe discharge in exacerbations of COPD. Thorax. 2015 Dec;70(12):1123-30. doi: 10.1136/thoraxjnl-2015-207188. Epub 2015 Jul 20.
citation: Murphy PB, Kumar A, Reilly C, Jolley C, Walterspacher S, Fedele F, Hopkinson NS, Man WD, Polkey MI, Moxham J, Hart N. Neural respiratory drive as a physiological biomarker to monitor change during acute exacerbations of COPD. Thorax. 2011 Jul;66(7):602-8. doi: 10.1136/thx.2010.151332. Epub 2011 May 19.