Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome (AVAPS)

Assiut University

Status: Completed

Conditions: Obesity Hypoventilation Syndrome (OHS)

Treatments: Device: AVAPS study was performed within 1 week of the CPAP titration attempt failure, using the auto-titrating EPAP (AE), the OmniLab Advanced +, System One device (Philips Respironics, Murrysville, PA, U.S.

Study type: Interventional

Funder types: Other

Identifiers

NCT06442163

5000231

Details and patient eligibility

About

It remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events, if maximum CPAP pressure is reached.

The goal was to examine the effects of 6 months of home AVAPS therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed CPAP titration due to persistent hypoxemia.

Full description

Obesity hypoventilation syndrome (OHS) is one of the leading indications of home non-invasive ventilation (NIV) initiation. In patients with OHS, NIV improves daytime vigilance, decreases PaCO2, improves sleep quality, and improves physical activity.

Thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (AVAPS-AE) ventilation on objective sleep quality and adherence to therapy in stable patients with OHS who failed CPAP titration.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All Clinically stable OHS patients with

  • Body mass index of 30 kg/m2 ,
  • Daytime hypercapnia (PaCO2 >45 mm Hg) who had failed to respond to CPAP therapy
  • had no other cause for their chronic respiratory failure and were naive to any PAP therapy.

Exclusion criteria

• Patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections)
• Patients who had been intubated during the last 3 months
• Patients who had received any other form of ventilatory support before hospital admission were also excluded from the study

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2

Experimental group

Description:

Each participant underwent initial baseline diagnostic polysomnograms (PSG) documenting the presence of OSA based on standard diagnostic criteria. After baseline (PSG) and patient's consent, patients performed full night CPAP titration in the sleep laboratory within 7 days of the baseline PSG, and AVAPS-AE titration.

Treatment:

Device: AVAPS study was performed within 1 week of the CPAP titration attempt failure, using the auto-titrating EPAP (AE), the OmniLab Advanced +, System One device (Philips Respironics, Murrysville, PA, U.S.