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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987661
• Other study ID #: Airtrap2013
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 1, 2018

Study information

• Verified date: February 2019
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	Helios Klinik Hagen	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	Weinmann Geräte für Medizin GmbH + Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep efficiency	Sleep efficiency is defined by the relation of "time in bed" to "total sleep time" in the overnight polysomnography protocol	2 nights
Primary	breathing frequency	breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night	2 nights
Secondary	mean pCO2 level	mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)	2 nights