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

NCT ID: NCT01986413

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

COPD; Chronic Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIPAP ST

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

Group Type: ACTIVE_COMPARATOR

pressure controlled ventilation BIPAP ST

Intervention Type: DEVICE

spontaneous timed pressure controled bilevel ventilation

NIV

Intervention Type: DEVICE

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.

IVAPS

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

Group Type: EXPERIMENTAL

volume assured pressure support IVAPS

Intervention Type: DEVICE

intelligent volume assured Pressure Support

NIV

Intervention Type: DEVICE

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.

Interventions

pressure controlled ventilation BIPAP ST

spontaneous timed pressure controled bilevel ventilation

Intervention Type: DEVICE

volume assured pressure support IVAPS

intelligent volume assured Pressure Support

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Stellar™ 150, ResMed; Stellar™ 150 with iVAPS; Stellar™ 150, ResMed

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role: lead

Responsible Party

Georg Nilius

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen

Locations

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

IVAPSleep 2013

Identifier Type: -

Identifier Source: org_study_id