Status:
COMPLETED
Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome
Lead Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Conditions:
Chronic Hypercapnic Respiratory Failure
Obesity Hypoventilation Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 treat...
Detailed Description
Method: Prospective, blind researchers, randomized, controlled non-inferiority and cost-effectiveness relationship, with two parallel open groups. 200 OHS patients will be divided into two groups by s...
Eligibility Criteria
Inclusion
- 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).
- Age between 18-80 years.
- 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.
- Overcome correctly a 30 minutes test of treatment with VNI in wakefulness.
Exclusion
- Psychophysical disability for questionnaires.
- Patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease.
- Chronic nasal obstruction that prevents the use of NIV.
- Pregnancy.
- No informed consent obtained.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04327336
Start Date
April 1 2020
End Date
July 14 2023
Last Update
November 27 2023
Active Locations (1)
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1
Juan F. Masa
Cáceres, Spain, 10003