The Role of HNHF to Improve Clinical Outcomes Following Severe AECOPD

NCT03899558 | Completed

• 1 other identifier: 242147
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Neural respiratory drive; Physiology; Respiratory muscles; COPD exacerbation; Ventilation; Nasal high-flow; High-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• Time to 30-day hospital readmission following index hospitalisation with AECOPD

  30-day readmission

  30 days following hospital discharge

Secondary Outcomes (17)

• Recruitment rate of eligible patients

  30 days following hospital discharge

• Adherence with completion of clinical outcome measures (symptom diary)

  30 days following hospital discharge

• Adherence with completion of clinical outcome measures (physical activity monitor)

  30 days following hospital discharge

• Adherence with completion of clinical outcome measures (spirometry)

  30 days following hospital discharge

• Participants' HNHF device usage

  30 days following hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

HNHF device (intervention) + usual care

Device: Humidified nasal high-flow device

Control

NO INTERVENTION

Usual care alone

Interventions

Humidified nasal high-flow device DEVICE

Humidified nasal high-flow device which delivers warmed, humidified air at flow rates of up to 60 litres per minute via a nasal cannula interface. Intended delivery at 30 L/min at 37 degrees Celsius, if tolerated.

Intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26194996 BACKGROUND

• 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.

  PMID: 21597112 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Nicholas Hart, PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 2, 2019
• Study Start: June 17, 2019
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-02

Locations

GB (1)