Humidified nasal high flow to improve clinical outcomes following severe exacerbations of chronic obstructive pulmonary disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15949009

Enrollment

Registered

2019-02-19

Start date

2019-04-01

Completion date

Unknown

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease Respiratory

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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, Rec	—

Measure

Time frame

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, Rec

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026