Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philips Respironics
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Study Overview
Brief Summary
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS).
The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to 18 years of age; less than or equal to 70 years of age
- •Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy
- •BMI greater than or equal to 30 kg/m2
- •Daytime PaCO2 greater than or equal to 45 mmHg
- •Apnea Hypopnea index (AHI) > 5
- •Daytime pH > 7.35
- •Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) > 70%
Exclusion Criteria
- •Acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator
- •Respiratory alkalosis (pH > 7.45), per investigator discretion
- •Emergency admissions on chronic respiratory failure
- •Hospitalization for respiratory exacerbation < 6 weeks prior to screening visit
- •Participants in whom PAP therapy is otherwise medically contraindicated
- •Impaired upper airway function. For example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of Non-invasive positive pressure ventilation (NPPV)
- •Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.
Arms & Interventions
AVAPS-AE
AVAPS-AE Mode of ventilation
Intervention: AVAPS-AE Mode of Therapy (Device)
Respironics OmniLab Advanced BiPAP S mode
OmniLab Advanced BiPAP S Mode of ventilation
Intervention: Respironics OnmiLab BiPAP S mode (Device)
Respironics OmniLab Advanced CPAP mode
OmniLab Advanced CPAP Mode of ventilation
Intervention: Respironics OmniLab Advanced CPAP mode (Device)
Outcomes
Primary Outcomes
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Time Frame: Screening & 6 weeks
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Secondary Outcomes
- Severe Respiratory Insufficiency Questionnaire (SRIQ)(Screening & 6 weeks)
- Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation(Screening & 6 weeks)
- Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)(Screening & 6 weeks)
- Apnea Hypopnea Index (AHI)(Screening & 6 weeks)
- Ventilator Adherence - Days Used(6 weeks)
- Nocturnal Transcutaneous Capnography (TcC02)(Screening & 6 weeks)
- Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency(Screening & 6 weeks)
- Epworth Sleepiness Scale(Screening & 6 weeks)
- Ventilator Adherence - Average Hours(6 weeks)
- Actigraphy(Screening & 6 weeks)
- Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices(Screening & 6 weeks)
- Reaction Time (Psychomotor Vigilance Test-PVT)(Screening & 6 weeks)
- Number of Participants With Need for Continued Oxygen Supplementation(Screening & 6 weeks)
- Room Air Sp02 Assessment Via Pulse Oximetry(Screening & 6 weeks)
- Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration(Screening & 6 weeks)