Clinical trial NCT04272879: HOT HMV 2: A Phase 4 Study
Official title: Home Oxygen Therapy - Home Mechanical Ventilation 2: A Phase 4 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have an admission to hospital with an acute exacerbation of COPD requiring non-invasive ventilation will be referred for assessment. Eligible patients will be referred by the critical care or appropriate respiratory team to a monthly assessment clinic for assessment of chronic hypercapnia.

Brief summary: Smoking related lung disease or Chronic Obstructive Pulmonary Disease (COPD) is characterised by periods of worsening symptoms termed exacerbations. In some patients these may be severe enough to require hospitalisation and support for their breathing. Patients who suffer a severe exacerbation requiring breathing support using mask ventilation (also termed non-invasive ventilation, NIV) have a high chance of being readmitted to hospital in the following 12 months. Recent evidence suggests that the provision of a breathing machine at home (home mechanical ventilation, HMV) may reduce the risk of readmission to hospital in selected patients.

Morbidity and mortality in the 12 months following a life-threatening exacerbation of COPD remain high. Recent data from the Lane Fox Clinical Respiratory Physiology Research Centre supports the addition of home non-invasive ventilation to standard care to improve admission-free survival in patients with persistent hypercapnia following a decompensated exacerbation of COPD.

The study is designed to evaluate the clinical implementation of the delivery of home non-invasive ventilation in COPD patients with persistent hypercapnia following an acute exacerbation of COPD to validate that the clinical benefit derived from the HOT-HMV trial is maintained when the home non-invasive ventilation is implemented into routine clinical practice.

Detailed description: Following publication of the home oxygen therapy-home mechanical ventilation (HOT-HMV) trial, the purpose of this study is to evaluate the clinical service delivery of home non-invasive ventilation (NIV) therapy in patients who have recently undergone, and recovered, from a life-threatening exacerbation of COPD.

This prospective cohort observational study is designed to evaluate the clinical implementation of the delivery of home non-invasive ventilation in COPD patients with persistent hypercapnia following an acute exacerbation of COPD to validate that the clinical benefit demonstrated by the HOT-HMV trial is maintained when the home non-invasive ventilation is incorporated into routine clinical practice.

Patients who have an admission to hospital with an acute exacerbation of COPD requiring non-invasive ventilation will be referred for assessment. Eligible patients will be referred by the critical care or appropriate respiratory team to a monthly assessment clinic for assessment of chronic hypercapnia. The total UK sample size will be 200 participants. St Thomas' critical care unit managed between 80-100 patients per year with non-invasive ventilation for life threatening exacerbation of COPD. This study will run over 4 years; therefore it is anticipated that 200 patients will be enrolled into the trial over this period. Patients will also be referred from peripheral hospitals to the Lane Fox Unit as a regional centre for home ventilation.

Eligibility criteria: Inclusion Criteria:

* Patient suspected or with proven diagnosis of COPD
* Admission to hospital with life-threatening exacerbation of COPD requiring acute NIV (at admission evidence of decompensated Chronic Respiratory Insufficiencies (PaCO2 \> 6kPa, pH \<7.35)
* Arterial partial pressure of carbon dioxide (PaCO2) \> 6kPa at discharge from hospital
* Discharge from hospital without combined home non-invasive ventilation and home oxygen therapy
* Patient willing to consider home non-invasive ventilation in addition to home oxygen therapy
* Patient suitable for home oxygen therapy (appropriate risk assessment)

Exclusion Criteria:

* Patient already established on home non-invasive ventilation and home oxygen therapy
* Patient unable to support home non-invasive ventilation e.g. unable to apply mask, lacking social support
* Patient on palliative care pathway
* Patient outside of usual catchment area for Lane Fox Respiratory Service

Primary outcomes:
measure: 12 month admission free survival
timeFrame: 12 months
Secondary outcomes:
measure: Barriers to receiving HOT-HMV treatment
timeFrame: 12 months
measure: What proportion of patients receive HOT-HMV as a proportion to those who received NIV acutely
timeFrame: 12 months
measure: What proportion of patients receive HOT-HMV as a proportion to those who are elgible to received HOT HMV
timeFrame: 12 months
measure: Cost of the clinical time and input to set patients up onto HOT HMV
timeFrame: 12 months
measure: Length of clinical time taken to set patients up onto HOT HMV
timeFrame: 12 months
measure: Report the clinical pathway and structure to deliver HOT HMV clinically
timeFrame: 12 months
measure: Machine malfunction and failure
timeFrame: 12 months
measure: Re admission to hospital
timeFrame: 28 days
measure: Tolerability of HOT HMV: How patients perceive they are tolerating the HOT HMV
timeFrame: 12 months
measure: Patients Quality of Life
timeFrame: 6 weeks, 3 months, 6 months and 12 months
measure: Patients Quality of Life
timeFrame: 6 weeks, 3 months, 6 months and 12 months
measure: Adherence to HOT HMV
timeFrame: 6 weeks, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation
Study officials:
affiliation: Guys & St Thomas NHS Foundation Trust
name: Nick Hart, MD
role: STUDY_CHAIR
References: