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

NCT01987661 | Completed

• 1 other identifier: Airtrap2013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; NIV; Airtrapping; Ventimotion2

Outcome Measures

Primary Outcomes (1)

• breathing frequency

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

  2 nights

Secondary Outcomes (1)

• mean pCO2 level

  2 nights

Other Outcomes (1)

• Sleep efficiency

  2 nights

Study Arms (2)

bilevel ventilation BIPAP ST

ACTIVE COMPARATOR

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

Device: BIPAP ST

BIPAP ST plus Airtrap

EXPERIMENTAL

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

Device: BIPAP ST; Device: Airtrap

Interventions

BIPAP ST DEVICE

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

Also known as: Ventimotion 2

BIPAP ST plus Airtrap; bilevel ventilation BIPAP ST

Airtrap 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.

Also known as: Ventimotion 2, Weinmann

BIPAP ST plus Airtrap

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable respiratory situation
• Clinically required NIV
• Capable of giving consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead
• Weinmann Geräte für Medizin GmbH + Co. KG: collaborator

Study Sites (1)

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Georg Nilius, MD

  Helios Klinik Hagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Helios Klinik Hagen Ambrock, Klinik für Pneumologie

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

DE (1)