AVAPS-AE Efficacy Study

Philips

Status: Completed

Conditions: Obesity Hypoventilation Syndrome

Treatments: Device: Respironics OmniLab Advanced CPAP mode; Device: Respironics OnmiLab BiPAP S mode; Device: AVAPS-AE Mode of Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368614

HRC-1006-AVAPS-AE-MS

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

AVAPS-AE

Experimental group

Description:

AVAPS-AE Mode of ventilation

Treatment:

Device: AVAPS-AE Mode of Therapy

Respironics OmniLab Advanced BiPAP S mode

Active Comparator group

Description:

OmniLab Advanced BiPAP S Mode of ventilation

Treatment:

Device: Respironics OnmiLab BiPAP S mode

Respironics OmniLab Advanced CPAP mode

Active Comparator group

Description:

OmniLab Advanced CPAP Mode of ventilation

Treatment:

Device: Respironics OmniLab Advanced CPAP mode