COPD ExacerbationHOT-HMV2NCT04272879
HOT HMV 2: A Phase 4 Study
An observational study of COPD Exacerbation, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Observational Group
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Oxygen Therapy - Home Mechanical Ventilation 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.
Read the 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
- Being tested
- Observational Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational GroupOther
Those requiring NIV following an acute exacerbation of COPD
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month admission free survival
How many patients were not admitted to hospital during the 12 months following initiation of NIV and still alive
Measured: 12 months
Secondary outcomes (12)
Barriers to receiving HOT-HMV treatment
Evaluating what are the barriers for patients to receive HOT HMV treatment within a clinical service
Measured: 12 months
What proportion of patients receive HOT-HMV as a proportion to those who received NIV acutely
Evaluating the proportion of patients who received NIV acutely vs those who are eligible to receive HOT HMV from the clinical service
Measured: 12 months
What proportion of patients receive HOT-HMV as a proportion to those who are elgible to received HOT HMV
Evaluating the proportion of patients are eligble to receive HOT HMV vs those who actually receive HOT HMV from the clinical service
Measured: 12 months
Cost of the clinical time and input to set patients up onto HOT HMV
What does it cost to set someone up onto HOT HMV
Measured: 12 months
Length of clinical time taken to set patients up onto HOT HMV
How long does it take a clinician to set someone up onto HOT HMV
Measured: 12 months
Report the clinical pathway and structure to deliver HOT HMV clinically
Establish a detail report outlining the clinical pathway and structure required of the clinical team to deliver HOT HMV clinically
Measured: 12 months
Machine malfunction and failure
Determine the reliability of the NIV machines issued clinically by monitoring their malfunction and failure rates
Measured: 12 months
Re admission to hospital
How many patients are readmitted to hospital within 28 days from set up onto HOT HMV
Measured: 28 days
Tolerability of HOT HMV: How patients perceive they are tolerating the HOT HMV
How patients perceive they are tolerating the HOT HMV
Measured: 12 months
Patients Quality of Life
Patients health related QoL by completing the Severe Respiratory Insufficiency questionnaire (SRI)
Measured: 6 weeks, 3 months, 6 months and 12 months
Patients Quality of Life
Patients health related QoL by completing the COPD assessment test (CAT).
Measured: 6 weeks, 3 months, 6 months and 12 months
Adherence to HOT HMV
Patients Adherence to their HOT HMV prescription taken from the datacard in their machine
Measured: 6 weeks, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 May 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Hart, MD, Study chair, Guys & St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272879
- Sponsor's protocol ID
- 228411
- Acronym
- HOT-HMV2
- Status last verified
- Sep 2021
- First submitted
- 10 Feb 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Oxygen Therapy - Home Mechanical Ventilation 2: A Phase 4 Study
- ClinicalTrials.gov ID
- NCT04272879
- Acronym / sponsor ID
- HOT-HMV2 / 228411
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational GroupThose requiring NIV following an acute exacerbation of COPD | Other | – |
Primary outcome
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
12 secondary outcomes
Barriers to receiving HOT-HMV treatment
Time frame: 12 months
What proportion of patients receive HOT-HMV as a proportion to those who received NIV acutely
Time frame: 12 months
What proportion of patients receive HOT-HMV as a proportion to those who are elgible to received HOT HMV
Time frame: 12 months
Cost of the clinical time and input to set patients up onto HOT HMV
Time frame: 12 months
Length of clinical time taken to set patients up onto HOT HMV
Time frame: 12 months
Report the clinical pathway and structure to deliver HOT HMV clinically
Time frame: 12 months
Machine malfunction and failure
Time frame: 12 months
Re admission to hospital
Time frame: 28 days
Tolerability of HOT HMV: How patients perceive they are tolerating the HOT HMV
Time frame: 12 months
Patients Quality of Life
Time frame: 6 weeks, 3 months, 6 months and 12 months
Patients Quality of Life
Time frame: 6 weeks, 3 months, 6 months and 12 months
Adherence to HOT HMV
Time frame: 6 weeks, 3 months, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Hart, MD study chair
Guys & St Thomas NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 month admission free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.