Overview

This trial is active, not recruiting.

Conditions copd, hypercapnic respiratory failure
Treatments bipap st, airtrap
Sponsor Institut für Pneumologie Hagen Ambrock eV
Collaborator Weinmann Geräte für Medizin GmbH + Co. KG
Start date October 2013
End date July 2016
Trial size 15 participants
Trial identifier NCT01987661, Airtrap2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.
bipap st Ventimotion 2
non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
(Experimental)
one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.
bipap st Ventimotion 2
non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
airtrap Ventimotion 2, Weinmann
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.

Primary Outcomes

Measure
breathing frequency
time frame: 2 nights

Secondary Outcomes

Measure
mean pCO2 level
time frame: 2 nights

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
Principal investigator Georg Nilius, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Institut für Pneumologie Hagen Ambrock eV.