Neuromuscular DiseasesNCT03289715
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
A study testing On Demand Humidification system Mark 2 in people with Neuromuscular Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial summary
Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- On Demand Humidification system Mark 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jan 2018to 31 Jul 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 of age; < 85 years of age
- Participants with a neuromuscular disorder who:
- Require 24 hour mechanical ventilation in some form through tracheostomy, mask or mouth piece
- Can be ambulatory for at least a few hours during the day while using a heat and moisture exchange device (HME) or no humidification
- Can part of the day use a heated pass-over humidification system while on their ventilator (overnight, for example).
- Able to provide feedback/articulate via some form of communication
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- Patients using a Trilogy ventilator
- Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).
- Patients that are willing to participate and are able to consent and sign the informed consent form. (Patients with the functional capacity for medical decision-making).
Who cannot join
- Clinically unstable, i.e.,
- Acute respiratory failure
- Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
- Uncontrolled cardiac ischemia or arrhythmias
- Any participant determined as inappropriate for the study by the Principal Investigator
- Patients suffering from metastatic or terminal cancer
- Patients lacking the functional capacity for medical decision-making.
Trial locations and contacts
1 site in 1 country.
About this study
Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.
- Conditions
- Neuromuscular Diseases
- Being tested
- On Demand Humidification system Mark 2
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On Demand Humidification system Mark 2Device
The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test.
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | on demand humidification Receives: Device: On Demand Humidification system Mark 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimum comfortable amount of on-demand humidification
questionnaire based on Borg Scale and Visual Analog scale
Measured: 3 hours
optimum comfortable amount of on-demand humidification
heart rate
Measured: 3 hours
optimum comfortable amount of on-demand humidification
breathing rate
Measured: 3 hours
optimum comfortable amount of on-demand humidification
SpO2
Measured: 3 hours
optimum comfortable amount of on-demand humidification
transcutaneous CO2
Measured: 3 hours
optimum comfortable amount of on-demand humidification
number of mucus clearance events
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start12 Jan 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289715
- Sponsor's protocol ID
- ICBE-2-16558
- Status last verified
- Oct 2018
- First submitted
- 15 Sep 2017
- Last updated
- 10 Oct 2018
- 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 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03289715
- Acronym / sponsor ID
- ICBE-2-16558
- Conditions
- Neuromuscular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 21 Sep 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.
Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Device: On Demand Humidification system Mark 2on demand humidification |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 of age; < 85 years of age
- Participants with a neuromuscular disorder who:
- Able to provide feedback/articulate via some form of communication
- Patients using a Trilogy ventilator
- Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).
Key exclusion criteria (7 listed)
- Clinically unstable, i.e.,
- Patients suffering from metastatic or terminal cancer
- Patients lacking the functional capacity for medical decision-making.
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 |
|---|---|---|
| On Demand Humidification system Mark 2The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test. | Device | arm 1 |
Primary outcome
optimum comfortable amount of on-demand humidification
Time frame: 3 hours
questionnaire based on Borg Scale and Visual Analog scale
optimum comfortable amount of on-demand humidification
Time frame: 3 hours
heart rate
optimum comfortable amount of on-demand humidification
Time frame: 3 hours
breathing rate
optimum comfortable amount of on-demand humidification
Time frame: 3 hours
SpO2
optimum comfortable amount of on-demand humidification
Time frame: 3 hours
transcutaneous CO2
optimum comfortable amount of on-demand humidification
Time frame: 3 hours
number of mucus clearance events
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 10 Oct 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On Demand Humidification system Mark 2 in people with Neuromuscular Diseases, run by Philips Clinical & Medical Affairs Global 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 9 inclusion and 7 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 10 Oct 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?
optimum comfortable amount of on-demand humidification (time frame: 3 hours). The study lists 6 primary outcomes in all. 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 10 Oct 2018.