The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation
NCT03506906
Apnea, Chronic Disease
Solingen, North Rhine-Westphalia, Germany
View Trial DetailsNCT Number: NCT03085537
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.
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Notify Me18 year–85 year
All sexes
Observational
Hospital universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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 (%)
Time frame: screening visit
age in years
Time frame: screening visit
sex: man or woman
Time frame: screening visit
asociated with starting mechanical ventilation
Time frame: screening visit
PaCo2 measured by blood gas test (mmHg) < 45
Time frame: screening visit
questionaire of sleep quality with ventilation.
Time frame: recorded date on screening visit
pressure or volume controlled modes. select the option at ventilator setings
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
Time frame: recorded date on screening visit
Kind of tuve, simple or doublé between patient and ventilator
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
Time frame: recorded date on screening visit
complying or not mínimum hours to recruiting (4h)
Corporacion Parc Tauli
Other
Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.
Acronym: PRE-HVNI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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