Perception of positive pressure assisted expiration using the non-invasive ventilation mode "Pursed-Lip Breathing Ventilation (PLBV)" in lung healthy, spontanously breathing volunteers

Perception of positive pressure assisted expiration using the non-invasive ventilation mode "Pursed-Lip Breathing Ventilation (PLBV)" in lung healthy, spontanously breathing volunteers - P-PLBV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022306

Enrollment

Registered

2020-06-26

Start date

2020-06-29

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers J44

Interventions

Group 1: At the beginning of the examination, all volunteers are equipped with a non-invasive ventilation mask connected to a bacterial/viral filter. Spontanous breathing in the PLBV mode with an insp

6 mbar static + 2 mbar dynamic PLBV

4 mbar static + 4 mbar PLBV). Measurements will be repeated 3 times for a duration of 2 minutes for each ventilation mode. During that period, the variables airway pressure, airway flow, endexpiratory

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: written informed consent, age 18 years or > 18, male/female/d

Exclusion criteria

Exclusion criteria: General Contraindications: Denial of consent at any phase of the examination acute or chronic lung disease Cardiovascular disease with impact on physical abilities Adipositas BMI =35 kg/m2 language barrier Contraindications for NIV: severe facial skin disease head and brain injury pneumothorax/ air embolism general myopathy lack of cognitive or physical adequacy anatomical facial malformation (clefts) mask phobia acute severe congestive heart failure trigeminal neuralgia with severe hypersensibility in the facial area the mask is placed in severe epistaxis (nousebleed) Contraindications for electrical impedance tomography: cardiac pace maker implanted cardioverter or defibrillator intracardiac vitia

Design outcomes

Primary

Measure	Time frame
Perception of the dynamic pressure support during expiration in the PLBV mode in comparison to a static expiratory pressure support (10-pointed scale: comfortable - not tolerable).	—

Secondary

Measure	Time frame
(1) most comfortable expiratory pressure support (Forced-Choice-method), (2) respiratory rate, (3) tidal volume, (4) endaxpiratory CO2, (5) intrahoracal gas volumine, measured by electrical impedance tomography, (6) heart rate, (7) non-invasive blood pressure, (8) oxygen saturation	—

Countries

Germany

Contacts

Public ContactJohannes Spaeth

Universitätsklinikum Freiburg, Klinik für Anäethsiologie und Intensivmedizin,

johannes.spaeth@uniklinik-freiburg.de076127023080

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026