Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Chronic Hypercapnic Respiratory Failure; COPD

Treatments: Device: volume assured pressure support IVAPS; Device: NIV; Device: pressure controlled ventilation BIPAP ST

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986413

IVAPSleep 2013

Details and patient eligibility

About

Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation.

20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.

Full description

Non invasive ventilation (NIV) is one of the major medical innovations of the last 30 years. Especially continuous positive airway pressure (CPAP) is the established Gold Standard in obstructive sleep apnea (OSA) treatment.

NIV with bilevel ventilation (BiPAP-ST) is the established Gold Standard in acute hypercapnic respiratory failure, especially in exacerbated COPD.

Still, the adaption of CPAP in OSA is less complicated than a bilevel therapy in hypercapnic failure. The adjustment of NIV requires not only the definition of expiration pressure (PEEP) but also of inspiration pressure support. Only adequate pressure difference guarantees effective ventilatory assistance and an improvement of alveolar ventilation. The pressure changes need to be defined by the physician, as well as the breathing frequency.

Ventilation can furthermore be controlled by a target volume (volume controlled) or a target pressure (pressure controlled).

Moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea and are hard to accustom to a respiratory mask.

There is a lack of systematic studies addressing the effects of different ventilator settings on sleep and life quality, as well as studies about the necessary monitoring extent during the NIV initiation.

Enrollment: 21 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable respiratory insufficiency
• Hypercapnia >50 mmHG
• Clinically required NIV
• Capable of giving consent

Exclusion criteria

• Existing ventilatory support
• Invasive ventilation
• Any other severe physical disease that requires immediate medical assistance
• Acute hypercapnic decompensation with pH <7.30 in routine BGA
• Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
• Participation in a clinical trial within the last 4 weeks
• Pregnancy or nursing period
• Drug addiction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

BIPAP ST

Active Comparator group

Description:

one night, NIV with pressure controlled ventilation (BIPAP ST) with individually titrated pressure parameters.

Treatment:

Device: pressure controlled ventilation BIPAP ST

Device: NIV

IVAPS

Experimental group

Description:

one night, NIV with volume assured pressure support (IVAPS).The pressure parameters will be adjusted according to the BIPAP pressure levels.

Treatment:

Device: NIV

Device: volume assured pressure support IVAPS