Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome
- Conditions
- Obesity Hypoventilation SyndromeChronic Hypercapnic Respiratory Failure
- Interventions
- Device: Automatic Non invasive ventilation titrationDevice: Manual Non invasive ventilation titration
- Registration Number
- NCT04327336
- Lead Sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Automatic Automatic Non invasive ventilation titration In this group the ventilator will run in an automatic mode (AVAPS) with the same Phillips A40 ventilator. Manual Manual Non invasive ventilation titration In this group non invasive mechanical ventilation will be manually titrated during a polysomnography. The Philips A40 ventilator will be used in Spontaneous-Timed (ST) mode.
- Primary Outcome Measures
Name Time Method Change in PaCO2 between arms 1 year Arterial blood gases while room air breathing expressed in mmHg
- Secondary Outcome Measures
Name Time Method Cost-effectiveness analysis by QALY 1 year Cost-effectiveness analysis based on the quality adjusted life year (QALY) Differences in within trial costs will be related with the differences in effectiveness (QALY) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.
Change in subjective daytime sleepiness 1 year Sleepiness evaluated by Epworth sleepiness scale, range from 0 to 24, being 0 the best result and 24 the worst.
Change in Quality of life measured by Short Form-36 (SF36), Physical component 1 year Quality of life measured by Short Form-36 (SF36) Physical component,range from 0 to 100, being 0 the worst result and 100 the best result.
Change in Bicarbonate arterial blood concentration 1 year Arterial blood gases while breathing room air expressed in mmol/L
Cost-effectiveness analysis by primary outcome 1 year Cost-effectiveness analysis based on the primary outcome in mmHg Differences in within trial costs will be related with the differences in effectiveness (primary outcome) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.
Change in Quality of life measured by Euroqol 5D. 1 year Quality of life measured by Euroqol 5D, range from 0 to 1, being 0 the worst result and 1 the best result .
Change in PaO2 1 year Arterial blood gases while breathing room air expressed PaO2 in mmHg
Change in polysomnographic Sleep periods 1 year Standard polysomnography. time of sleep periods (Stage 1,2,3,4 and REM) in minutes.
Incidental cardiovascular events 1 year New hypertension diagnosis or anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or instable angina, nonfatal stroke or transient ischemic attack or for heart failure episode, and cardiovascular death. Data obtained from official electronic health care databases
Health care resources utilization: Hospital duration 1 year Hospital duration measured in days of hospitalization
Health care resources utilization: emergency visits 1 year Emergency visits measured in number of events
Health care resources utilization: primary care visits 1 year Primary care visits measured in number of events
Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ) 1 year Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ), range from 0 to 120, being 0 the worst result and 120 the best result .
Change in Quality of life measured by visual analogical wellbeing scale (VAWS) 1 year Quality of life measured by visual analogical well-being scale (VAWS), range from 0 to 100, being 0 the worst result and 120 the best result .
Change in Quality of life measured by Short Form-36 (SF36), Mental component 1 year Quality of life measured by Short Form-36 (SF36) Mental component,range from 0 to 100, being 0 the worst result and 100 the best result.
Change in Apnea-Hypopnea index 1 year Standard polysomnography, number of apneas and hypoapneas per sleep hour
Change in Sleep time with Oxygen saturation below 90% 1 year Standard polysomnography, percentage of sleep time with oxygen saturation below 90%
Change in Oxygen desaturation index 1 year Standard polysomnography, number of 3% or more Oxygen desaturations per sleep hour
Change in polysomnographic parameters: Total Sleep time (TTS) 1 year Standard polysomnography, time in minutes
Change in the blood pressure monitoring at baseline and after a year The blood pressure will be monitored during 24 hours with a Blood Pressure Monitoring device before (baseline) and after intervention (1 year) in both arms measured in mmHg. Change in the mean blood pressure will be compared between arms
Health care resources utilization: ICU duration 1 year ICU duration measured in days of UCI admissions
Incidence of new adverse event 1 year Number of adverse events based in CTCAE v4.0
Side effects 1 year Incidence or side effects of NIV in follow-up visits: excessive noise, headache, claustrophobia, difficulty in sleep conciliation or maintenance, expiration discomfort.
Change in Arousal Index 1 year Standard polysomnography, number of arousals per sleep hour
Health care resources utilization: Hospital admission 1 year Hospital admission measured in number of events
Health care resources utilization: ICU admission 1 year ICU admission measured in numbers of events
Health care resources utilization: specialist visits 1 year Specialist visits measured in number of events
Change in pH 1 year Arterial blood gases while breathing room air
Trial Locations
- Locations (1)
Juan F. Masa
🇪🇸Cáceres, Spain