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

NCT01987661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-11

No results posted yet for this study

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.

Conditions

  • COPD
  • Hypercapnic Respiratory Failure

Interventions

DEVICE

BIPAP ST

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

DEVICE

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.

Sponsors & Collaborators

  • Weinmann Geräte für Medizin GmbH + Co. KG

    collaborator INDUSTRY

  • Institut für Pneumologie Hagen Ambrock eV

    lead INDUSTRY

Principal Investigators

  • Georg Nilius, MD · Helios Klinik Hagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-03-01
Completion
2018-03-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01987661 on ClinicalTrials.gov