An observational study in Neuromuscular Diseases, Obesity Hypoventilation Syndrome and Lung Disease, Restrictive, sponsored by Corporacion Parc Tauli. Completed at 3 sites in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Corporacion Parc Tauli · Observational
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 40 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
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Patients affected by restrictive lung disease, neuromuscular disorders or hypoventilation-obesity with home non-invasive mechanical ventilation.
Exclusion Criteria:
Asynchronies Index
Number of respiratory events registered automatically by digital diagnosis platform
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
Leaks
Presence or not of intencionals and unintencionals leaks recorded
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
Measure by pulsy oxymetry (%)
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
age in years
Time frame: screening visit
Demographics parameters- sex
sex: man or woman
Time frame: screening visit
Pathology indication
asociated with starting mechanical ventilation
Time frame: screening visit
PaCO2
PaCo2 measured by blood gas test (mmHg) \< 45
Time frame: screening visit
Pittsburgh Sleep Quality Index. (PSQI)
questionaire of sleep quality with ventilation.
Time frame: screening visit
Mode Ventilator
pressure or volume controlled modes. select the option at ventilator setings
Time frame: 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
Time frame: recorded date on screening visit
Tube
Kind of tuve, simple or doublé between patient and ventilator
Time frame: 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
Time frame: recorded date on screening visit
Compliance ventilator
complying or not mínimum hours to recruiting (4h)
Time frame: recorded date on screening visit
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Corporacion Parc Tauli