Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: BIPAP ST one night, NIV with pressure controlled ventilation (BIPAP ST) with individually titrated pressure parameters. |
Device: pressure controlled ventilation BIPAP ST
spontaneous timed pressure controled bilevel ventilation
Other Names:
Device: NIV
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.
Other Names:
|
| Experimental: IVAPS one night, NIV with volume assured pressure support (IVAPS).The pressure parameters will be adjusted according to the BIPAP pressure levels. |
Device: volume assured pressure support IVAPS
intelligent volume assured Pressure Support
Other Names:
Device: NIV
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of respiratory events during non invasive ventilation [2 nights]
Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea
Secondary Outcome Measures
- Sleep efficiency [2 nights]
Relation between "time in bed" and "total sleep time" measured by a polysomnography under non invasive ventilation.
Other Outcome Measures
- mean PCO2-level during non invasive ventilation [2 nights]
Mean pCO2 level over night measured transcutaneously with a polysomnography under non invasive ventilation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Stable respiratory insufficiency
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Hypercapnia >50 mmHG
-
Clinically required NIV
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Capable of giving consent
Exclusion Criteria:
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Existing ventilatory support
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Invasive ventilation
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Any other severe physical disease that requires immediate medical assistance
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Acute hypercapnic decompensation with pH <7.30 in routine BGA
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Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
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Participation in a clinical trial within the last 4 weeks
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Pregnancy or nursing period
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Drug addiction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helios Klinik Hagen | Hagen | NRW | Germany | 58091 |
Sponsors and Collaborators
- Institut für Pneumologie Hagen Ambrock eV
- ResMed
Investigators
- Principal Investigator: Georg Nilius, MD, Helios Klinik Hagen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IVAPSleep 2013