Status:

COMPLETED

HOT HMV 2: A Phase 4 Study

Lead Sponsor:

Guy's and St Thomas' NHS Foundation Trust

Conditions:

COPD Exacerbation

Eligibility:

All Genders

18+ years

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 requ...

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 (N...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 30 2021

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT04272879

Start Date

May 1 2018

End Date

April 30 2021

Last Update

October 1 2021

Active Locations (1)

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1

Guys and St Thomas NHS Foundation

London, United Kingdom, SE1 7EH

HOT HMV 2: A Phase 4 Study | DecenTrialz