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

N/ACompletedNCT01987661

Institut für Pneumologie Hagen Ambrock eV10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD Hypercapnic Respiratory Failure

Interventions

AirtrapDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

breathing frequency

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

Time frame: 2 nights

Secondary Outcomes

mean pCO2 level

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