Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilati… (NCT04327336) | Clinical Trial Compass
CompletedNot Applicable
Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome
Spain200 participantsStarted 2020-04-01
Plain-language summary
Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Obesity Hypoventilation Syndrome defined by obesity (IMC≥30) and Hypercapnic respiratory failure (PCO 2\> 45 mm Hg) in stable phase (PH≥7.35 without clinical signs of worsening in at least one previous month).
âś“. Age between 18-80 years.
âś“. Absence of other diseases causing hypercapnia as moderate or severe chronic obstructive pulmonary disease (FEV1\> 70% predicted if FEV1 / FVC \<70), neuromuscular, thoracic wall or metabolic disease; d) Absence of narcolepsy or restless legs syndrome.
âś“. Overcome correctly a 30 minutes test of treatment with VNI in wakefulness.
Exclusion criteria
âś•. Psychophysical disability for questionnaires.
âś•. Patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease.
âś•. Chronic nasal obstruction that prevents the use of NIV.
âś•. Pregnancy.
âś•
What they're measuring
1
Change in PaCO2 between arms
Timeframe: 1 year
Trial details
NCT IDNCT04327336
SponsorSociedad Española de NeumologĂa y CirugĂa Torácica