Humidified nasal high flow to improve clinical outcomes following severe exacerbations of chronic obstructive pulmonary disease
| ISRCTN | ISRCTN15949009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15949009 |
| ClinicalTrials.gov number | NCT03899558 |
| Secondary identifying numbers | CPMS 40985 |
- Submission date
- 18/02/2019
- Registration date
- 19/02/2019
- Last edited
- 07/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the UK. COPD patients suffer with episodes of worsening breathing symptoms called exacerbations. 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 30 days. COPD thus imposes immense burdens on the National Health Service and patients. This study 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.
Who can participate?
Patients admitted to St Thomas’ Hospital, London with COPD exacerbations
What does the study involve?
Before discharge, participants are randomly allocated to receive either usual care alone or usual care plus a HNHF device, which they are trained to use for a regular period daily. Usual care includes inhalers, steroids and may include antibiotics. Participants are 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 enables evaluation of the clinical effects of HNHF on re-exacerbations, readmissions, breathlessness, physical activity and quality of life. Device usage is also measured. Participants who receive devices are interviewed to explore their experiences. After the 30-day home follow-up period, a sub-group of participants undergoes detailed breathing tests during and after exercise to explore the effects of HNHF on the respiratory system.
What are the possible benefits and risks of participating?
It is known that HNHF reduces frequency of hospital admissions and exacerbations and improves symptoms and quality of life in stable COPD patients. This study investigates whether it also has these beneficial effects in COPD patients recovering from severe exacerbations. There are no reported adverse side effects of using the device.
Where is the study run from?
Guy’s and St Thomas’ NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2018 to August 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Prof. Nicholas Hart
Nicholas.hart@gstt.nhs.uk
2. Dr Rebecca D’Cruz
Rebecca.DCruz@gstt.nhs.uk
Contact information
Scientific
Lane Fox Research Unit
St Thomas’ Hospital
Westminister Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)207 188 8070 |
|---|---|
| Nicholas.hart@gstt.nhs.uk |
Scientific
Lane Fox Research Unit
St Thomas’ Hospital
Westminister Bridge Road
London
SE1 7EH
United Kingdom
 ORCID ID |
0000-0001-5245-9911 |
|---|---|
| Phone | +44 (0)207 188 8070 |
| Rebecca.DCruz@gstt.nhs.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The role of nasal high-flow to reduce 30-day hospital readmissions following severe exacerbations of chronic obstructive pulmonary disease: a mixed-methods feasibility study |
| Study acronym | NHF Post-AECOPD |
| Study objectives | The primary objective is to estimate the effects of humidified nasal high flow on clinical outcomes that are important to patients and healthcare services (30-day hospital readmission, re-exacerbation, breathlessness, health-related quality of life and physical activity), explore patients’ experiences of using the device and understand the effects it has on the breathing system during physical exertion. |
| Ethics approval(s) | Approved 20/03/2019, London – Harrow Research Ethics Committee, Bristol HRA Centre, Level 3, Block B Whitefriars, Lewins Mead, Bristol, BS1 2NT, Tel: +44 (0)2071048056, Email: nrescommittee.london-harrow@nhs.net, ref: 19/LO/0194 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | 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 nasal high-flow (NHF) device, which they will be trained to use for a regular period daily. Usual care includes inhalers, and 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 NHF 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 NHF on the respiratory system. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nasal high-flow (NHF) device |
| Primary outcome measure | Estimate of the standard deviation for and possible effect size of 30-day hospital readmission to inform the design of a Phase III multicentre RCT: measured using symptom diaries and medical records at weeks 1, 2, 3, 4 following hospital discharge |
| Secondary outcome measures | Current secondary outcome measures as of 22/03/2019: Feasibility: 1. Recruitment rate of eligible patients, measured using the number of eligible patients consenting to participate in the study during the period of recruitment. 2. Adherence with completion of outcome measures, measured by reviewing adherence to the study protocol following completion of individual participants’ study completion 3. Participant’s NHF device usage, measured from the device following individual participants’ study completion Clinical: obtaining estimates of standard deviations and possible effect size of: 1. Admission and non-admission re-exacerbation, measured using symptom diaries at weeks 1, 2, 3, 4 2. Breathlessness, measured daily using symptom diaries, modified Borg and VAS scores for 30 days following hospital discharge and weekly Multidimensional Dyspnoea Profile (MDP) in weeks 1, 2, 3, 4 3. Physical activity, measured continuously using wrist-worn physical activity monitors for the 30-day follow-up period 4. Health-related quality of life, measured using COPD Assessment Test and Clinical COPD Questionnaire at admission, discharge and weekly at weeks 1, 2, 3, 4 5. Lung function, measured using weekly measurements of spirometry at weeks 1, 2, 3, 4 Acceptability of NHF, assessed using qualitative evaluation – a semi-structured interview at week 4 Proof-of-concept sub-study: 1. Inspiratory capacity, measured during incremental exercise testing 2. Breathlessness, measured using mBorg score and MDP before, during and after exercise testing 3. Neural respiratory drive, measured continuously using electromyography during exercise testing 4. Pulmonary mechanics, including pulmonary pressures and flow, measured continuously using a pressure transducer and pneumotachograph during exercise testing 4. Time to recover from maximal breathlessness, measured with a timer, as time from maximal mBorg score to pre-exercise baseline score Previous secondary outcome measures: Feasibility: 1, Recruitment rate of eligible patients, measured using the number of eligible patients consenting to participate in the study during the period of recruitment. 2. Adherence with completion of outcome measures, measured by reviewing adherence to the study protocol (completion of all measured variables) following completion of individual participants’ study completion 3. Participant’s NHF device usage, measured directly from the device following individual participants’ study completion Clinical: obtaining estimates of standard deviations and possible effect size of: 1. Non-admission re-exacerbation, measured using symptom diaries at weeks 1, 2, 3, 4 2. Breathlessness, measured daily using symptom diaries, modified Borg and VAS scores for 30 days following hospital discharge and weekly Multidimensional Dyspnoea Profile (MDP) in weeks 1, 2, 3, 4 3. Physical activity, measured continuously using wrist-worn physical activity monitors for the 30-day follow-up period 4. Health-related quality of life, measured using COPD Assessment Test, Clinical COPD Questionnaire at admission, discharge and weekly at weeks 1, 2, 3, 4 5. Lung function, measured using weekly measurements of spirometry at weeks 1, 2, 3, 4 Acceptability of NHF, assessed using qualitative evaluation – a semi-structured interview at week 4 Proof-of-concept sub-study: 1. Peak exercise capacity, measured using peak work during maximal exercise testing 2. Breathlessness, measured during mBorg score and MDP during exercise testing 3. Neural respiratory drive, measured continuously using electromyography during exercise testing 4. Time to recover from maximal breathlessness, measured with a timer, time from maximal mBorg score to pre-exercise baseline score |
| Overall study start date | 01/09/2018 |
| Completion date | 01/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Emergency hospital admission with a primary diagnosis of AECOPD 2. Aged 40-80 years 3. > = 10 pack year smoking history 4. Body mass index < = 35kg/m2 5. Cognitively and linguistically able to follow English instructions, provide informed consent and complete the study protocol 6. To be discharged home following the hospitalisation in a home environment deemed safe by the investigator to perform home assessments 7. Patient lives in the catchment area served by the Integrated Respiratory Team at Guy’s and St Thomas’ NHS Foundation Trust |
| Key exclusion criteria | 1. Chest radiograph shows pneumothorax 2. Requirement for acute NIV during index hospitalisation or established on home PAP 3. Significant chronic respiratory failure (PaCO2 > 7.0) 4. Clinically significant obstructive sleep apnoea requiring treatment 5. Allergies to latex, metals or local anaesthetic 6. Broken or inflamed skin at the second intercostal space parasternal chest wall areas 7. Psychological or social factors that would impair compliance with the study protocol 8. 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 9. Planned travel away from home in the 30-day post-discharge period |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 24/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)2071887188 |
|---|---|
| R&D@gstt.nhs.uk | |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The results of this study will be published in a high-impact factor peer-reviewed journal and will be presented at international conferences. A lay results summary will be provided to study participants upon study completion. The trialists do not plan to provide additional study documents. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 06/01/2025 | 07/01/2025 | Yes | No |
Editorial Notes
07/01/2025: Publication reference added.
09/09/2022: The following changes have been made:
1. The intention to publish date has been changed from 01/08/2022 to 01/01/2023.
2. The final enrolment number has been changed from 20 to 18.
14/04/2021: The ClinicalTrials.gov number was added.
09/04/2021: Recruitment for this study is no longer paused and the following changes have been made:
1. The recruitment end date has been changed from 01/04/2021 to 24/03/2021.
2. The total final enrolment number has been added.
21/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/07/2019: The ethics approval was added.
22/03/2019: The condition has been changed from "Specialty: Respiratory Disorders, Primary sub-specialty: Chronic Obstructive Pulmonary Disease; Health Category: Respiratory; Disease/Condition: Chronic lower respiratory diseases" to "Chronic obstructive pulmonary disease" following a request from the NIHR.
22/03/2019: The secondary outcome measures were updated.
21/02/2019: Contact details updated.
