HOT HMV 2: A Phase 4 Study

NCT ID: NCT04272879

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-04-30

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.

Conditions

COPD Exacerbation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observational Group

Those requiring NIV following an acute exacerbation of COPD

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Hart, MD

Role: STUDY_CHAIR

Guys & St Thomas NHS Foundation Trust

Locations

Guys and St Thomas NHS Foundation

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

228411

Identifier Type: -

Identifier Source: org_study_id