Influence of Pseudomonas aeruginosa colonisation status on respiratory muscle function in adult Cystic Fibrosis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00008786

Enrollment

Registered

2015-06-17

Start date

2015-07-20

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

cystic fibrosis E84.0

Interventions

Group 1: adult CF-patients will be evaluated on their respiratory muscle strength and function regarding their status of Pseudomonas aeruginosa infection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Underlying disease: Cystic fibrosis (diagnosis proven via sweat test and/or genetic assessment) • Stable patient= no exazerbation in the last 30 days • Signed consent form • Age = 18 years

Exclusion criteria

Exclusion criteria: • last hospitalisation due to acute clinical worsening less than 1 months ago • i.v.-antibiotics in the last 30 days • status post lung transplantation • Age < 18 years

Design outcomes

Primary

Measure	Time frame
PTImus to evaluate the respiratory muscle work load and reserve regarding the status of Pseudomonas aeruginosa infection (Evaluation of the infection status of Pseudomonas aeruginosa analogous to the Leeds-criteria, initially division in 4 groups: 1. chronic Pseudomonas aeruginosa infection (>50% positive sputum samples) 2. intermittent Pseudomonas aeruginosa infection ( = 50% positive sputum samples) 3. no Pseudomonas aeruginosa (negative sputum samples in the last 12 months) 4. never had Pseudomonas aeruginosa infection) Afterwards subsuming the 4 subgroups: group 1 and 2 to group A (“Pseudomonas-positive”), group 3 and 4 to group B (“Pseudomonas-negative”). The aim of this study is to evaluate in adult CF-patients whether a chronic infection with Pseudomonas aeruginosa reduces the respiratory muscle strength and impairs respiratory muscle function. PTImus= pressure-time index of the respiratory muscles= (mean PI/PImax) x (ti/ttot), where PI is airway pressure during inspiration, calculated as 5 x P0.1 x ti (ttot= total breathing cycle time; ti = inspiratory time)	—

Measure

Time frame

PTImus to evaluate the respiratory muscle work load and reserve regarding the status of Pseudomonas aeruginosa infection (Evaluation of the infection status of Pseudomonas aeruginosa analogous to the Leeds-criteria, initially division in 4 groups: 1. chronic Pseudomonas aeruginosa infection (>50% positive sputum samples) 2. intermittent Pseudomonas aeruginosa infection ( = 50% positive sputum samples) 3. no Pseudomonas aeruginosa (negative sputum samples in the last 12 months) 4. never had Pseudomonas aeruginosa infection) Afterwards subsuming the 4 subgroups: group 1 and 2 to group A (“Pseudomonas-positive”), group 3 and 4 to group B (“Pseudomonas-negative”). The aim of this study is to evaluate in adult CF-patients whether a chronic infection with Pseudomonas aeruginosa reduces the respiratory muscle strength and impairs respiratory muscle function. PTImus= pressure-time index of the respiratory muscles= (mean PI/PImax) x (ti/ttot), where PI is airway pressure during inspiration, calculated as 5 x P0.1 x ti (ttot= total breathing cycle time; ti = inspiratory time)

—

Secondary

Measure	Time frame
• Pneumological assessment: o Spirometry and Bodyplethysmography o standardised 6-minute-walk test (including a.o. capillary blood gas analysis, pulsoxymetry, assessment of dyspnoe (BORG-Scale), measurement of walking distance (m)) o respiratory muscle testing: PImax, PEmax, P0.1, Sn Pna, Calculation of the specific respiratory impedance (P0.1*ti/VT (VT= tidal volume)); P0.1/PImax o data on quality of life: assessment via the Cystic Fibrosis Questionnaire-Revised-(CFQ-R)	—

Measure

Time frame

• Pneumological assessment: o Spirometry and Bodyplethysmography o standardised 6-minute-walk test (including a.o. capillary blood gas analysis, pulsoxymetry, assessment of dyspnoe (BORG-Scale), measurement of walking distance (m)) o respiratory muscle testing: PImax, PEmax, P0.1, Sn Pna, Calculation of the specific respiratory impedance (P0.1*ti/VT (VT= tidal volume)); P0.1/PImax o data on quality of life: assessment via the Cystic Fibrosis Questionnaire-Revised-(CFQ-R)

—

Countries

Germany

Contacts

Public ContactFriederike Magnet

Kliniken der Stadt Köln gGmbHLungenklinik Merheim

magnetf@kliniken-koeln.de022189073250

Outcome results

None listed

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