Effectiveness of Noninvasive Ventilation Adjusted Automatically in the Obesity Hypoventilation Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Change in PaCO2 between arms
Study Overview
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 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.
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 simple randomization 1:1 and followed for one year. The premise of non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in PCO2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age, sex, body mass index in intention-to-treat and per-protocol analysis. The cost-effectiveness will be performed by Bayesian techniques with sensitivity analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Two investigators (named Investigator 1 and Investigator 2) participate in each center, with different tasks. Investigator 1 is responsible of randomization and will be aware of the study group assigned to the patient. Investigator 2 will collect in each visit health resource utilization, specific and QoL tests and laboratory test results. Investigator 2 does not know the study arm.
Patients will not be informed about the ventilator settings and the menu of the ventilator will be locked, so they cannot access to ventilator data.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
- •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 Criteria
- •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.
- •No informed consent obtained.
Outcomes
Primary Outcomes
Change in PaCO2 between arms
Time Frame: 1 year
Arterial blood gases while room air breathing expressed in mmHg
Secondary Outcomes
- Change in polysomnographic Sleep periods(1 year)
- Cost-effectiveness analysis by QALY(1 year)
- Change in subjective daytime sleepiness(1 year)
- Change in Quality of life measured by Short Form-36 (SF36), Physical component(1 year)
- Change in Bicarbonate arterial blood concentration(1 year)
- Cost-effectiveness analysis by primary outcome(1 year)
- Change in Quality of life measured by Euroqol 5D.(1 year)
- Change in PaO2(1 year)
- Incidental cardiovascular events(1 year)
- Health care resources utilization: Hospital duration(1 year)
- Health care resources utilization: emergency visits(1 year)
- Health care resources utilization: primary care visits(1 year)
- Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)(1 year)
- Change in Quality of life measured by visual analogical wellbeing scale (VAWS)(1 year)
- Change in Quality of life measured by Short Form-36 (SF36), Mental component(1 year)
- Change in Apnea-Hypopnea index(1 year)
- Change in Sleep time with Oxygen saturation below 90%(1 year)
- Change in pH(1 year)
- Change in Oxygen desaturation index(1 year)
- Change in polysomnographic parameters: Total Sleep time (TTS)(1 year)
- Change in the blood pressure monitoring(at baseline and after a year)
- Health care resources utilization: ICU duration(1 year)
- Incidence of new adverse event(1 year)
- Side effects(1 year)
- Change in Arousal Index(1 year)
- Health care resources utilization: Hospital admission(1 year)
- Health care resources utilization: ICU admission(1 year)
- Health care resources utilization: specialist visits(1 year)
Investigators
Juan F. Masa
Principal Investigator
Sociedad Española de Neumología y Cirugía Torácica