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

German: Einfluss Von Gesichertem Atemminutenvolumen Auf Schlafqualität Und Häufigkeit Respiratorischer Ereignisse Bei Patienten Mit Nicht Invasiver Beatmung (NIV)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01986413
Enrollment
21
Registered
2013-11-18
Start date
2013-07-31
Completion date
2014-06-30
Last updated
2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Chronic Hypercapnic Respiratory Failure

Keywords

COPD, chronic hypercapnic respiratory failure, NIV, respiratory events, IVAPS

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.

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.

Interventions

DEVICEpressure controlled ventilation BIPAP ST

spontaneous timed pressure controled bilevel ventilation

DEVICEvolume assured pressure support IVAPS

intelligent volume assured Pressure Support

DEVICENIV

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.

Sponsors

ResMed
CollaboratorINDUSTRY
Institut für Pneumologie Hagen Ambrock eV
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of respiratory events during non invasive ventilation2 nightsUnintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea

Secondary

MeasureTime frameDescription
Sleep efficiency2 nightsRelation between time in bed and total sleep time measured by a polysomnography under non invasive ventilation.

Other

MeasureTime frameDescription
mean PCO2-level during non invasive ventilation2 nightsMean pCO2 level over night measured transcutaneously with a polysomnography under non invasive ventilation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026