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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986413
• Other study ID #: IVAPSleep 2013
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: March 23, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hypercapnic Respiratory Failure
• COPD
• Hypercapnia
• Respiratory Insufficiency

Intervention

Device:
• pressure controlled ventilation BIPAP ST
spontaneous timed pressure controled bilevel ventilation
• volume assured pressure support IVAPS
intelligent volume assured Pressure Support
• 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.

Locations

Country	Name	City	State
Germany	Helios Klinik Hagen	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mean PCO2-level during non invasive ventilation	Mean pCO2 level over night measured transcutaneously with a polysomnography under non invasive ventilation	2 nights	No
Primary	Number of respiratory events during non invasive ventilation	Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea	2 nights	No
Secondary	Sleep efficiency	Relation between "time in bed" and "total sleep time" measured by a polysomnography under non invasive ventilation.	2 nights	No