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

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Hypercapnic Respiratory Failure; COPD

Treatments: Device: BIPAP ST; Device: Airtrap

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987661

Airtrap2013

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

bilevel ventilation BIPAP ST

Active Comparator group

Description:

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

Treatment:

Device: BIPAP ST

BIPAP ST plus Airtrap

Experimental group

Description:

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

Treatment:

Device: Airtrap

Device: BIPAP ST