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Completed

NCT Number: NCT01987661

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Hypercapnic Respiratory Failure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIPAP ST

Device

non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.

Other names: Ventimotion 2

Airtrap

Device

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

Primary outcomes

  1. breathing frequency

    Time frame: 2 nights

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

Secondary outcomes

  1. mean pCO2 level

    Time frame: 2 nights

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

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • Weinmann Geräte für Medizin GmbH + Co. KG

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2013
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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