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NCT Number: NCT04272879

HOT HMV 2: A Phase 4 Study

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.

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Key information

Conditions

COPD Exacerbation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Group

Other

Those requiring NIV following an acute exacerbation of COPD

Primary outcomes

  1. 12 month admission free survival

    Time frame: 12 months

    How many patients were not admitted to hospital during the 12 months following initiation of NIV and still alive

Secondary outcomes

  1. Barriers to receiving HOT-HMV treatment

    Time frame: 12 months

    Evaluating what are the barriers for patients to receive HOT HMV treatment within a clinical service

  2. What proportion of patients receive HOT-HMV as a proportion to those who received NIV acutely

    Time frame: 12 months

    Evaluating the proportion of patients who received NIV acutely vs those who are eligible to receive HOT HMV from the clinical service

  3. What proportion of patients receive HOT-HMV as a proportion to those who are elgible to received HOT HMV

    Time frame: 12 months

    Evaluating the proportion of patients are eligble to receive HOT HMV vs those who actually receive HOT HMV from the clinical service

  4. Cost of the clinical time and input to set patients up onto HOT HMV

    Time frame: 12 months

    What does it cost to set someone up onto HOT HMV

  5. Length of clinical time taken to set patients up onto HOT HMV

    Time frame: 12 months

    How long does it take a clinician to set someone up onto HOT HMV

  6. Report the clinical pathway and structure to deliver HOT HMV clinically

    Time frame: 12 months

    Establish a detail report outlining the clinical pathway and structure required of the clinical team to deliver HOT HMV clinically

  7. Machine malfunction and failure

    Time frame: 12 months

    Determine the reliability of the NIV machines issued clinically by monitoring their malfunction and failure rates

  8. Re admission to hospital

    Time frame: 28 days

    How many patients are readmitted to hospital within 28 days from set up onto HOT HMV

  9. Tolerability of HOT HMV: How patients perceive they are tolerating the HOT HMV

    Time frame: 12 months

    How patients perceive they are tolerating the HOT HMV

  10. Patients Quality of Life

    Time frame: 6 weeks, 3 months, 6 months and 12 months

    Patients health related QoL by completing the Severe Respiratory Insufficiency questionnaire (SRI)

  11. Patients Quality of Life

    Time frame: 6 weeks, 3 months, 6 months and 12 months

    Patients health related QoL by completing the COPD assessment test (CAT).

  12. Adherence to HOT HMV

    Time frame: 6 weeks, 3 months, 6 months and 12 months

    Patients Adherence to their HOT HMV prescription taken from the datacard in their machine

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

Home Oxygen Therapy - Home Mechanical Ventilation 2: A Phase 4 Study

Acronym: HOT-HMV2

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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