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

Primary Purpose

COPD, Chronic Hypercapnic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pressure controlled ventilation BIPAP ST
volume assured pressure support IVAPS
NIV
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, chronic hypercapnic respiratory failure, NIV, respiratory events, IVAPS

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Helios Klinik Hagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BIPAP ST

IVAPS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of respiratory events during non invasive ventilation
Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea

Secondary Outcome Measures

Sleep efficiency
Relation between "time in bed" and "total sleep time" measured by a polysomnography under non invasive ventilation.

Full Information

First Posted
November 11, 2013
Last Updated
March 23, 2015
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT01986413
Brief Title
Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation
Official Title
German: Einfluss Von Gesichertem Atemminutenvolumen Auf Schlafqualität Und Häufigkeit Respiratorischer Ereignisse Bei Patienten Mit Nicht Invasiver Beatmung (NIV)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Hypercapnic Respiratory Failure
Keywords
COPD, chronic hypercapnic respiratory failure, NIV, respiratory events, IVAPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIPAP ST
Arm Type
Active Comparator
Arm Description
one night, NIV with pressure controlled ventilation (BIPAP ST) with individually titrated pressure parameters.
Arm Title
IVAPS
Arm Type
Experimental
Arm Description
one night, NIV with volume assured pressure support (IVAPS).The pressure parameters will be adjusted according to the BIPAP pressure levels.
Intervention Type
Device
Intervention Name(s)
pressure controlled ventilation BIPAP ST
Other Intervention Name(s)
Stellar™ 150, ResMed
Intervention Description
spontaneous timed pressure controled bilevel ventilation
Intervention Type
Device
Intervention Name(s)
volume assured pressure support IVAPS
Other Intervention Name(s)
Stellar™ 150 with iVAPS
Intervention Description
intelligent volume assured Pressure Support
Intervention Type
Device
Intervention Name(s)
NIV
Other Intervention Name(s)
Stellar™ 150, ResMed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of respiratory events during non invasive ventilation
Description
Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea
Time Frame
2 nights
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
Relation between "time in bed" and "total sleep time" measured by a polysomnography under non invasive ventilation.
Time Frame
2 nights
Other Pre-specified Outcome Measures:
Title
mean PCO2-level during non invasive ventilation
Description
Mean pCO2 level over night measured transcutaneously with a polysomnography under non invasive ventilation
Time Frame
2 nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, MD
Organizational Affiliation
Helios Klinik Hagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany

12. IPD Sharing Statement

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

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