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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987661
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
Weinmann Geräte für Medizin GmbH + Co. KG
Information provided by (Responsible Party):
Georg Nilius, Institut für Pneumologie Hagen Ambrock eV

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.


Condition or disease Intervention/treatment Phase
COPD Hypercapnic Respiratory Failure Device: BIPAP ST Device: Airtrap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
Study Start Date : October 2013
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Arm Intervention/treatment
Active Comparator: bilevel ventilation BIPAP ST
one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.
Device: BIPAP ST
non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
Other Name: Ventimotion 2

Experimental: BIPAP ST plus Airtrap
one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.
Device: BIPAP ST
non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
Other Name: Ventimotion 2

Device: Airtrap

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.

Other Name: Ventimotion 2, Weinmann




Primary Outcome Measures :
  1. breathing frequency [ Time Frame: 2 nights ]
    breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night


Secondary Outcome Measures :
  1. mean pCO2 level [ Time Frame: 2 nights ]
    mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)


Other Outcome Measures:
  1. Sleep efficiency [ Time Frame: 2 nights ]
    Sleep efficiency is defined by the relation of "time in bed" to "total sleep time" in the overnight polysomnography protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987661


Locations
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Germany
Helios Klinik Hagen
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Weinmann Geräte für Medizin GmbH + Co. KG
Investigators
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Principal Investigator: Georg Nilius, MD Helios Klinik Hagen
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Responsible Party: Georg Nilius, Head of Helios Klinik Hagen Ambrock, Klinik für Pneumologie, Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01987661    
Other Study ID Numbers: Airtrap2013
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Keywords provided by Georg Nilius, Institut für Pneumologie Hagen Ambrock eV:
COPD
NIV
Airtrapping
Ventimotion2
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases