Clinical trial NCT04327336: Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome
Official title: Effectiveness of Noninvasive Ventilation Adjusted Automatically in the Obesity Hypoventilation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hypercapnic Respiratory Failure
Obesity Hypoventilation Syndrome
Keywords: Chronic respiratory failure
Obesity
Non invasive mechanical ventilation
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, double arm, double blind controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Age between 18-80 years.
3. 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.
4. Overcome correctly a 30 minutes test of treatment with VNI in wakefulness.

Exclusion Criteria:

1. Psychophysical disability for questionnaires.
2. Patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease.
3. Chronic nasal obstruction that prevents the use of NIV.
4. Pregnancy.
5. No informed consent obtained.

Primary outcomes:
measure: Change in PaCO2 between arms
timeFrame: 1 year
Secondary outcomes:
measure: Cost-effectiveness analysis by primary outcome
timeFrame: 1 year
measure: Cost-effectiveness analysis by QALY
timeFrame: 1 year
measure: Change in subjective daytime sleepiness
timeFrame: 1 year
measure: Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 1 year
measure: Change in Quality of life measured by visual analogical wellbeing scale (VAWS)
timeFrame: 1 year
measure: Change in Quality of life measured by Euroqol 5D.
timeFrame: 1 year
measure: Change in Quality of life measured by Short Form-36 (SF36), Mental component
timeFrame: 1 year
measure: Change in Quality of life measured by Short Form-36 (SF36), Physical component
timeFrame: 1 year
measure: Change in Bicarbonate arterial blood concentration
timeFrame: 1 year
measure: Change in PaO2
timeFrame: 1 year
measure: Change in pH
timeFrame: 1 year
measure: Change in polysomnographic Sleep periods
timeFrame: 1 year
measure: Change in Arousal Index
timeFrame: 1 year
measure: Change in Apnea-Hypopnea index
timeFrame: 1 year
measure: Change in Oxygen desaturation index
timeFrame: 1 year
measure: Change in Sleep time with Oxygen saturation below 90%
timeFrame: 1 year
measure: Change in polysomnographic parameters: Total Sleep time (TTS)
timeFrame: 1 year
measure: Change in the blood pressure monitoring
timeFrame: at baseline and after a year
measure: Incidental cardiovascular events
timeFrame: 1 year
measure: Health care resources utilization: Hospital admission
timeFrame: 1 year
measure: Health care resources utilization: Hospital duration
timeFrame: 1 year
measure: Health care resources utilization: ICU admission
timeFrame: 1 year
measure: Health care resources utilization: ICU duration
timeFrame: 1 year
measure: Health care resources utilization: emergency visits
timeFrame: 1 year
measure: Health care resources utilization: primary care visits
timeFrame: 1 year
measure: Health care resources utilization: specialist visits
timeFrame: 1 year
measure: Incidence of new adverse event
timeFrame: 1 year
measure: Side effects
timeFrame: 1 year
Other outcomes:
measure: Adherent vs. non-adherent to noninvasive ventilation therapy subgroups
timeFrame: 1 year
measure: Sleep apnea severity subgroup
timeFrame: 1 year
measure: Hypercapnia severity subgroup
timeFrame: 1 year
measure: Systemic hypertension subgroup
timeFrame: 1 year
measure: Hypercapnia resolution subgroup
timeFrame: 1 year
Locations:
city: Cáceres
country: Spain
facility: Juan F. Masa
Study officials:
affiliation: Hospital San Pedro de Alcantara
name: Juan F Masa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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