Neuromuscular DiseasesPRE-HVNINCT03085537
Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform
An observational study of Neuromuscular Diseases and Obesity Hypoventilation Syndrome, run by Corporacion Parc Tauli at 3 sites in Spain.
Trial summary
The main objective will be to determine the effectiveness of home non-invasive ventilation by flow-time and time-pressure curves analysis in a cohort of patients with this treatment by digital diagnosis platform. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuromuscular Diseases, Obesity Hypoventilation Syndrome, Lung Disease, Restrictive
- How many people
- 40 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Oct 2016to 30 Oct 2021
- How long will I take part?
- 1 Day
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by restrictive lung disease, neuromuscular disorders or hypoventilation-obesity with home non-invasive mechanical ventilation.
Who may be able to join
- Home non-invasive mechanical ventilation and clinical stability at least of 6 months ( no acute episode with admission on 2 months before)
- Mean Ventilator compliance > 4 h/ per night on screening visit
- Signed informed consent form previously
Who cannot join
- Ventilation with oxygen join system.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Vall d´Hebron
Barcelona, 08035
Hospital universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Corporación Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.
The main objective will be to determine the effectiveness of home non-invasive ventilation by flow-time and time-pressure curves analysis in a cohort of patients with this treatment by digital diagnosis platform.
Read the detailed description
A multicenter study with observational prospective design will be implemented on 3 spanish hospitals in Barcelona. Inclusion criteria will be equivalent sample size of patients with restrictive lung disease, neuromuscular pathology and hypoventilation-obesity.
Digital diagnosis platform will be used to incorporate and unify signals of different medical devices: a pneumotachograph on branch ventilator that captures pressure and flow-time signals, inductance plethysmography used to like a patient effort sensor and portable pulse oximeter recordings. Nocturnal polygraphic or polysomnographic tracings performed and recorded on sites will be processed systematically by main asynchronies diagnosis algorithms between patient and ventilator. These algorithms providing global and fractionated asynchronies count based on time, leaks or saturation criteria which will be used to compared effective ventilation phases and phases with nocturnal desaturations. Therefore, prevalence and asynchronies model on home NIV can be determine establishing the correlation between desaturation phases and respiratory events and identifying minimum tolerable leak level to keep adequate ventilation.
- Keywords
- home monitoring, Non-invasive mechanical ventilation
- Medical subject headings
- Neuromuscular Diseases, Obesity Hypoventilation Syndrome, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchronies Index
Number of respiratory events registered automatically by digital diagnosis platform
Measured: One week after screening visit if the subject comply inclusion criteria. Asynchronies analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night
Secondary outcomes (12)
Leaks
Presence or not of intencionals and unintencionals leaks recorded
Measured: One week after screening visit if the subject comply inclusion criteria. leaks analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night
Oxygen saturation
Measure by pulsy oxymetry (%)
Measured: One week after screening visit if the subject comply inclusion criteria. Oxygen saturation analysis will be performed once by nocturnal polygraphy once (cross-sectional design) on site during one night
Demographics parameters- age
age in years
Measured: screening visit
Demographics parameters- sex
sex: man or woman
Measured: screening visit
Pathology indication
asociated with starting mechanical ventilation
Measured: screening visit
PaCO2
PaCo2 measured by blood gas test (mmHg) < 45
Measured: screening visit
Pittsburgh Sleep Quality Index. (PSQI)
questionaire of sleep quality with ventilation.
Measured: screening visit
Mode Ventilator
pressure or volume controlled modes. select the option at ventilator setings
Measured: recorded date on screening visit
Interfaces
kind of mask using between the patient and ventilator. Total face mask, nasal mask, oro-nasal mask depend of patient characteristics
Measured: recorded date on screening visit
Tube
Kind of tuve, simple or doublé between patient and ventilator
Measured: recorded date on screening visit
Antyrebreathing system
Kind of system that avoid rebreathing CO2: acitve valve, leak controlled mask, leak controlled tube or double circuit
Measured: recorded date on screening visit
Compliance ventilator
complying or not mínimum hours to recruiting (4h)
Measured: recorded date on screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Oct 2016
- Primary completion30 Sep 2018
- Study completion30 Oct 2021
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.
- 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
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, Manel Lujan-Torne, Corporacion Parc Tauli
- Investigators
- Manel Lujan, Principal investigator, Corporation PT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085537
- Sponsor's protocol ID
- 13/088
- Acronym
- PRE-HVNI
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 9 Mar 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.
- ClinicalTrials.gov ID
- NCT03085537
- Acronym / sponsor ID
- PRE-HVNI / 13/088
- Keywords
- home monitoring, Non-invasive mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 21 Mar 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.
The main objective will be to determine the effectiveness of home non-invasive ventilation by flow-time and time-pressure curves analysis in a cohort of patients with this treatment by digital diagnosis platform.
Detailed description
A multicenter study with observational prospective design will be implemented on 3 spanish hospitals in Barcelona. Inclusion criteria will be equivalent sample size of patients with restrictive lung disease, neuromuscular pathology and hypoventilation-obesity.
Digital diagnosis platform will be used to incorporate and unify signals of different medical devices: a pneumotachograph on branch ventilator that captures pressure and flow-time signals, inductance plethysmography used to like a patient effort sensor and portable pulse oximeter recordings. Nocturnal polygraphic or polysomnographic tracings performed and recorded on sites will be processed systematically by main asynchronies diagnosis algorithms between patient and ventilator. These algorithms providing global and fractionated asynchronies count based on time, leaks or saturation criteria which will be used to compared effective ventilation phases and phases with nocturnal desaturations. Therefore, prevalence and asynchronies model on home NIV can be determine establishing the correlation between desaturation phases and respiratory events and identifying minimum tolerable leak level to keep adequate ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by restrictive lung disease, neuromuscular disorders or hypoventilation-obesity with home non-invasive mechanical ventilation.
Key inclusion criteria (3 listed)
- Home non-invasive mechanical ventilation and clinical stability at least of 6 months ( no acute episode with admission on 2 months before)
- Mean Ventilator compliance > 4 h/ per night on screening visit
- Signed informed consent form previously
Key exclusion criteria (1 listed)
- Ventilation with oxygen join system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asynchronies Index
Time frame: One week after screening visit if the subject comply inclusion criteria. Asynchronies analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night
Number of respiratory events registered automatically by digital diagnosis platform
12 secondary outcomes
Leaks
Time frame: One week after screening visit if the subject comply inclusion criteria. leaks analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night
Oxygen saturation
Time frame: One week after screening visit if the subject comply inclusion criteria. Oxygen saturation analysis will be performed once by nocturnal polygraphy once (cross-sectional design) on site during one night
Demographics parameters- age
Time frame: screening visit
Demographics parameters- sex
Time frame: screening visit
Pathology indication
Time frame: screening visit
PaCO2
Time frame: screening visit
Pittsburgh Sleep Quality Index. (PSQI)
Time frame: screening visit
Mode Ventilator
Time frame: recorded date on screening visit
Interfaces
Time frame: recorded date on screening visit
Tube
Time frame: recorded date on screening visit
Antyrebreathing system
Time frame: recorded date on screening visit
Compliance ventilator
Time frame: recorded date on screening visit
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 9 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Manel Lujan principal investigator
Corporation PT
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Obesity Hypoventilation Syndrome, run by Corporacion Parc Tauli at 3 sites in Spain.
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 3 inclusion and 1 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Asynchronies Index (time frame: One week after screening visit if the subject comply inclusion criteria. Asynchronies analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night). 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 9 Mar 2022.