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

NCT ID: NCT01987661

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-03-01

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.

Conditions

COPD; Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bilevel ventilation BIPAP ST

one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.

Group Type: ACTIVE_COMPARATOR

BIPAP ST

Intervention Type: DEVICE

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

BIPAP ST plus Airtrap

one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.

Group Type: EXPERIMENTAL

BIPAP ST

Intervention Type: DEVICE

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

Airtrap

Intervention Type: DEVICE

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.

Interventions

BIPAP ST

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Ventimotion 2; Ventimotion 2, Weinmann

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weinmann Geräte für Medizin GmbH + Co. KG

INDUSTRY

Sponsor Role: collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role: lead

Responsible Party

Georg Nilius

Head of Helios Klinik Hagen Ambrock, Klinik für Pneumologie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen

Locations

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Airtrap2013

Identifier Type: -

Identifier Source: org_study_id