- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085537
Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform (PRE-HVNI)
Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08035
- Hospital Vall D´Hebron
-
-
Barcelona
-
Hospitalet de Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
-
Sabadell, Barcelona, Spain, 08208
- Corporacion Sanitaria Parc Tauli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Ventilation with oxygen join system.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Presence or not of intencionals and unintencionals leaks recorded
|
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
|
Measure by pulsy oxymetry (%)
|
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
|
age in years
|
screening visit
|
Demographics parameters- sex
Time Frame: screening visit
|
sex: man or woman
|
screening visit
|
Pathology indication
Time Frame: screening visit
|
asociated with starting mechanical ventilation
|
screening visit
|
PaCO2
Time Frame: screening visit
|
PaCo2 measured by blood gas test (mmHg) < 45
|
screening visit
|
Pittsburgh Sleep Quality Index. (PSQI)
Time Frame: screening visit
|
questionaire of sleep quality with ventilation.
|
screening visit
|
Mode Ventilator
Time Frame: recorded date on screening visit
|
pressure or volume controlled modes.
select the option at ventilator setings
|
recorded date on screening visit
|
Interfaces
Time Frame: recorded date on screening visit
|
kind of mask using between the patient and ventilator.
Total face mask, nasal mask, oro-nasal mask depend of patient characteristics
|
recorded date on screening visit
|
Tube
Time Frame: recorded date on screening visit
|
Kind of tuve, simple or doublé between patient and ventilator
|
recorded date on screening visit
|
Antyrebreathing system
Time Frame: recorded date on screening visit
|
Kind of system that avoid rebreathing CO2: acitve valve, leak controlled mask, leak controlled tube or double circuit
|
recorded date on screening visit
|
Compliance ventilator
Time Frame: recorded date on screening visit
|
complying or not mínimum hours to recruiting (4h)
|
recorded date on screening visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Manel Lujan, Corporation PT
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Overnutrition
- Nutrition Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Respiratory Insufficiency
- Obesity
- Sleep Apnea, Obstructive
- Lung Diseases
- Hypoventilation
- Obesity Hypoventilation Syndrome
- Neuromuscular Diseases
Other Study ID Numbers
- 13/088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuromuscular Diseases
-
Brugmann University HospitalCompletedAnesthesia, General | Neuromuscular Transmission DisordersBelgium
-
University Hospital, ToursCompletedNeuromuscular Diseases in Children | Neuromuscular Diseases in InfantsFrance
-
National Institute of Nursing Research (NINR)TerminatedNeuromuscular DiseaseUnited States
-
Landon Pediatric FoundationCompleted
-
Institut de Myologie, FranceCompleted
-
Centre d'Investigation Clinique et Technologique...Association Française contre les Myopathies (AFM), ParisCompletedCommunication | Neuromuscular DiseaseFrance
-
Ottawa Hospital Research InstituteRecruiting
-
University of FloridaTerminated
-
Penwest Pharmaceuticals Co.TerminatedNeuromuscular DiseaseUnited Kingdom