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The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD

Primary Purpose

COPD, Hypercapnic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
BIPAP ST
Airtrap
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, NIV, Airtrapping, Ventimotion2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable respiratory situation
  • Clinically required NIV
  • Capable of giving consent

Exclusion Criteria:

  • 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

bilevel ventilation BIPAP ST

BIPAP ST plus Airtrap

Arm Description

one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.

one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.

Outcomes

Primary Outcome Measures

breathing frequency
breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night

Secondary Outcome Measures

mean pCO2 level
mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)

Full Information

First Posted
November 13, 2013
Last Updated
February 8, 2019
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01987661
Brief Title
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
Official Title
German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night. Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnic Respiratory Failure
Keywords
COPD, NIV, Airtrapping, Ventimotion2

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
bilevel ventilation BIPAP ST
Arm Type
Active Comparator
Arm Description
one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.
Arm Title
BIPAP ST plus Airtrap
Arm Type
Experimental
Arm Description
one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.
Intervention Type
Device
Intervention Name(s)
BIPAP ST
Other Intervention Name(s)
Ventimotion 2
Intervention Description
non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
Intervention Type
Device
Intervention Name(s)
Airtrap
Other Intervention Name(s)
Ventimotion 2, Weinmann
Intervention Description
Addional to the individally titrated BiPAP ventilation parameters the function "AirTrap Control" is added. AirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time.
Primary Outcome Measure Information:
Title
breathing frequency
Description
breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night
Time Frame
2 nights
Secondary Outcome Measure Information:
Title
mean pCO2 level
Description
mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)
Time Frame
2 nights
Other Pre-specified Outcome Measures:
Title
Sleep efficiency
Description
Sleep efficiency is defined by the relation of "time in bed" to "total sleep time" in the overnight polysomnography protocol
Time Frame
2 nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable respiratory situation Clinically required NIV Capable of giving consent Exclusion Criteria: 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

Learn more about this trial

The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD

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