Respiratory TherapyHomerunNCT03203577
Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure
A study testing Initiation of mechanical ventilation in people with Respiratory Therapy and Respiration, Artificial, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Therapy, Respiration, Artificial, Positive-Pressure Respiration
- What is being tested?
- Initiation of mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2015to May 2018
- Phase
- Interventional
- 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
Who may be able to join
- Indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements:
- arterial carbon dioxide > 6.0 kPa daytime or arterial or transcutaneous carbon dioxide > 6.0 kPa at night or orthopnea as a result of diaphragm paralysis
- Age > 18 years
- Existence, of a sufficient network (social or professional) according to the supervising HMV center making initiation of HMV at home possible and safe.
Who cannot join
- Patients who already have had HMV due to acute respiratory failure
- Necessity for invasive ventilatory support
- Patients admitted to a nursing home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initiation of Home Mechanical Ventilation at Home in a Selectve Group of Patients With Chronic Hypercapnic Respiratory Failure in the Netherlands
Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start.
Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation.
Read more
Study design: A nationwide non-inferiority multi-center randomized parallel active control study.
Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.
Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline.
Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total.
Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months.
Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.
- Conditions
- Respiratory Therapy, Respiration, Artificial, Positive-Pressure Respiration, Neuromuscular Diseases, Noninvasive Ventilation, Cost-Benefit Analysis
- Being tested
- Initiation of mechanical ventilation
- Medical subject headings
- Respiratory Aspiration, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of mechanical ventilationProcedure or surgery
Also called start of home mechanical ventialtion with telemonitoring
In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.
| Study group | Role | What they receive |
|---|---|---|
| Hospital initiation | Active comparator | Initiation of mechanical ventilation in hospital initiation of Home Mechanical ventilation takes place in a hospital; this makes this arm the standard care. Receives: Procedure: Initiation of mechanical ventilation |
| Home initiation | Experimental | Initiation of mechanical ventilation at home Initiation of mechanical ventilation in a patient's home setting with telemonitoring Receives: Procedure: Initiation of mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime arterial carbon dioxide
Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position
Measured: 6 months after initiation of mechanical ventilation
Secondary outcomes (4)
Quality of life
Health related quality of life by using the following questionnaires: SF 36, MRF 28, HADS, SRI
Measured: 6 months after initiation of mechanical ventilation
Lung function
evaluate lungfunction in time; with measurments of flow/volume in a sitting and horizontal position
Measured: 6 months after initation of mechanical ventilation
Nocturnal transcutaneous carbon dioxide and saturation
Nocturnal transcutaneous carbon dioxide and saturation in time
Measured: 6 months after initiation of mechanical ventilation
costs
evaluation of the costs during initiation and the follow-up for 6 months. This will be objective by using the EuroQol (EQ-5D) questionnaire
Measured: 6 months after initiation of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study startJul 2015
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory TherapyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Wijkstra, University Medical Center Groningen
- Investigators
- P.J. Wijkstra, Prof., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203577
- Sponsor's protocol ID
- ZonMw 80-83700-98-52003
- Other IDs
- NTR4683, METc 2014.529
- Acronym
- Homerun
- Status last verified
- Jun 2018
- First submitted
- 17 Feb 2017
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
van den Biggelaar RJM, Hazenberg A, Cobben NAM, Gaytant MA, Vermeulen KM, Wijkstra PJ. A Randomized Trial of Initiation of Chronic Noninvasive Mechanical Ventilation at Home vs In-Hospital in Patients With Neuromuscular Disease and Thoracic Cage Disorder: The Dutch Homerun Trial. Chest. 2020 Dec;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007. Epub 2020 Jul 16.
PubMed 32682770
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Home Mechanical Ventilation at Home in a Selectve Group of Patients With Chronic Hypercapnic Respiratory Failure in the Netherlands
- ClinicalTrials.gov ID
- NCT03203577
- Acronym / sponsor ID
- Homerun / ZonMw 80-83700-98-52003
- Conditions
- Respiratory Therapy, Respiration, Artificial, Positive-Pressure Respiration, Neuromuscular Diseases, Noninvasive Ventilation, Cost-Benefit Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Jun 2017 (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.
Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start.
Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation.
Study design: A nationwide non-inferiority multi-center randomized parallel active control study.
Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.
Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline.
Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total.
Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months.
Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital initiation | Active comparator | Procedure: Initiation of mechanical ventilationInitiation of mechanical ventilation in hospital initiation of Home Mechanical ventilation takes place in a hospital; this makes this arm the standard care. |
| Home initiation | Experimental | Procedure: Initiation of mechanical ventilationInitiation of mechanical ventilation at home Initiation of mechanical ventilation in a patient's home setting with telemonitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements:
- arterial carbon dioxide > 6.0 kPa daytime or arterial or transcutaneous carbon dioxide > 6.0 kPa at night or orthopnea as a result of diaphragm paralysis
- Age > 18 years
- Existence, of a sufficient network (social or professional) according to the supervising HMV center making initiation of HMV at home possible and safe.
Key exclusion criteria (3 listed)
- Patients who already have had HMV due to acute respiratory failure
- Necessity for invasive ventilatory support
- Patients admitted to a nursing home
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 |
|---|---|---|
| Initiation of mechanical ventilationAlso: start of home mechanical ventialtion with telemonitoringIn patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting. | Procedure or surgery | Home initiation, Hospital initiation |
Primary outcome
Daytime arterial carbon dioxide
Time frame: 6 months after initiation of mechanical ventilation
Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position
4 secondary outcomes
Quality of life
Time frame: 6 months after initiation of mechanical ventilation
Lung function
Time frame: 6 months after initation of mechanical ventilation
Nocturnal transcutaneous carbon dioxide and saturation
Time frame: 6 months after initiation of mechanical ventilation
costs
Time frame: 6 months after initiation of mechanical ventilation
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 18 Jun 2018.
- Derived from this study: PubMed 32682770van den Biggelaar RJM, Hazenberg A, Cobben NAM, Gaytant MA, Vermeulen KM, Wijkstra PJ. A Randomized Trial of Initiation of Chronic Noninvasive Mechanical Ventilation at Home vs In-Hospital in Patients With Neuromuscular Disease and Thoracic Cage Disorder: The Dutch Homerun Trial. Chest. 2020 Dec;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007. Epub 2020 Jul 16.
- 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.
P.J. Wijkstra, Prof. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initiation of mechanical ventilation in people with Respiratory Therapy and Respiration, Artificial, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 inclusion and 3 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 18 Jun 2018. 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 Netherlands. 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?
Daytime arterial carbon dioxide (time frame: 6 months after initiation of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203577, which also lists 1 linked publication.
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 18 Jun 2018.