HOT HMV 2: A Phase 4 Study

NCT04272879 | Completed

• 1 other identifier: 228411
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• 12 month admission free survival

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

  12 months

Secondary Outcomes (12)

• Barriers to receiving HOT-HMV treatment

  12 months

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

  12 months

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

  12 months

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

  12 months

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

  12 months

Interventions

Observational Group OTHER

Those requiring NIV following an acute exacerbation of COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

Study Officials

• Nick Hart, MD

  Guys & St Thomas NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: May 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)