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The Role of HNHF to Improve Clinical Outcomes Following Severe AECOPD

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ClinicalTrials.gov Identifier: NCT03899558
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Humidified nasal high-flow device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
HNHF device (intervention) + usual care
Device: Humidified nasal high-flow 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.

No Intervention: Control
Usual care alone



Primary Outcome Measures :
  1. Time to 30-day hospital readmission following index hospitalisation with AECOPD [ Time Frame: 30 days following hospital discharge ]
    30-day readmission


Secondary Outcome Measures :
  1. Recruitment rate of eligible patients [ Time Frame: 30 days following hospital discharge ]
    Feasibility outcome measure: assessed by proportion of patients who fulfil eligibility criteria who consent to participate.

  2. Adherence with completion of clinical outcome measures (symptom diary) [ Time Frame: 30 days following hospital discharge ]
    Feasibility outcome measure: assessed by completion of symptom diaries. Progression criterion = participant diaries completed by >70% of participants. Assessed at 30-days following hospital discharge.

  3. Adherence with completion of clinical outcome measures (physical activity monitor) [ Time Frame: 30 days following hospital discharge ]
    Feasibility outcome measure: assessed by usage of physical activity monitors. Progression criterion = usage >70% of participants. Measured from physical activity monitor computer downloads at 30-days following hospital discharge.

  4. Adherence with completion of clinical outcome measures (spirometry) [ Time Frame: 30 days following hospital discharge ]
    Feasibility outcome measure: assessed by completion of spirometry. Progression criterion = spirometry measured at every study assessment for >70% of participants.

  5. Participants' HNHF device usage [ Time Frame: 30 days following hospital discharge ]
    Feasibility outcome measure: usage hours accessed from the device at completion of participants' study participation for those participants allocated to the intervention arm.

  6. Acceptability of HNHF at home: semi-structured interviews [ Time Frame: 30 days following hospital discharge ]
    Qualitative evaluation: Use of semi-structured interviews after 30 days post-discharge following index hospitalisation to explore barriers and facilitators to device usage in intervention arm participants.

  7. Non-readmission AECOPD [ Time Frame: 30 days following hospital discharge ]
    Clinical outcome measure: the number of acute exacerbations of COPD that do not require hospitalisation will be recorded using symptom diaries.

  8. Breathlessness [ Time Frame: 30 days following hospital discharge ]
    Clinical outcome measure: breathlessness severity will be assessed using the modified Borg scale (minimum score = 0, indicating no breathlessness, maximum score = 10 indicating maximal intensity of breathlessness).

  9. Breathlessness [ Time Frame: 30 days following hospital discharge ]
    Clinical outcome measure: breathlessness severity will be assessed using the Multidimensional Dyspnoea Profile.

  10. Physical activity [ Time Frame: 30 days following hospital discharge ]
    Clinical outcome measure: daily physical activity (measured in counts per minute) will be quantified using a wrist-worn physical activity monitor which uses a triaxial accelerometer.

  11. Health-related quality of life: COPD Assessment Test [ Time Frame: 30 days following hospital discharge ]
    Clinical outcome measure: assessed using the COPD Assessment Test.

  12. Health-related quality of life: Clinical COPD Questionnaire [ Time Frame: 30 days following hospital discharge ]
    Clinical outcome measure: assessed using the Clinical COPD Questionnaire. Scored from 0 to 60, with higher scores indicative of worse disease-specific health-related quality of life.

  13. Inspiratory capacity [ Time Frame: 30 days following hospital discharge ]
    Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using a pneumotachograph.

  14. Breathlessness [ Time Frame: 30 days following hospital discharge ]
    Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using the modified Borg scale. This zero to ten scale measures breathlessness intensity, with higher scores representing more intense breathlessness. The score will be measured before exercise, at 2 minute intervals during exercise, at exercise cessation and during exercise recovery.

  15. Neural respiratory drive [ Time Frame: 30 days following hospital discharge ]
    Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using a parasternal and diaphragm electromyography using surface and nasogastric electrodes, respectively.

  16. Pulmonary pressures and flow [ Time Frame: 30 days following hospital discharge ]
    Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using a pressure transducer connected to a nasogastric catheter and a pneumotachograph.

  17. Time to recover from maximal breathlessness [ Time Frame: 30 days following hospital discharge ]
    Proof of concept study outcome: time from maximal breathlessness at peak exercise to pre-exercise modified Borg scale.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899558


Contacts
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Contact: Nicholas Hart, PhD 02071888070 ext 88070 nicholas.hart@gstt.nhs.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Nicholas Hart    02071888070    nicholas.hart@gstt.nhs.uk   
Contact: Rebecca D'Cruz    02071888070    rebecca.dcruz@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Nicholas Hart, PhD Guy's and St Thomas' NHS Foundation Trust

Publications:
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03899558     History of Changes
Other Study ID Numbers: 242147
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Neural respiratory drive
Physiology
Respiratory muscles
COPD exacerbation
Ventilation
Nasal high-flow
High-flow nasal cannula

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases