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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01987661

Enrollment

Registered

2013-11-19

Start date

2013-10-31

Completion date

2018-03-01

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Hypercapnic Respiratory Failure

Keywords

COPD, NIV, Airtrapping, Ventimotion2

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.

Interventions

DEVICEBIPAP ST

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

DEVICEAirtrap

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Sleep efficiency	2 nights	Sleep efficiency is defined by the relation of time in bed to total sleep time in the overnight polysomnography protocol

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026