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

February 8, 2019 updated by: Georg Nilius, Institut für Pneumologie Hagen Ambrock eV

German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Hagen, NRW, Germany, 58091
        • Helios Klinik Hagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Ventimotion 2, Weinmann

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breathing frequency
Time Frame: 2 nights
breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night
2 nights

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean pCO2 level
Time Frame: 2 nights
mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)
2 nights

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 nights

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Collaborators

Weinmann Geräte für Medizin GmbH + Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Airtrap2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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