Impact of High-Intensity-NPPV on cardiac and pulmonary function in stable hypercapnic COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007977

Enrollment

Registered

2015-04-13

Start date

2015-04-14

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

J96.1 J44

Interventions

Group 1: The study has a cross-over design: The patients in arm 1 will be ventilated noninvasively (by nose or mouth/nose mask) during the night, the first 6 weeks with low-intensity settings (IPAP =

EPAP 5±2 mbar

pressure support (PSV)

respiratory rate = 12±2/min)then they are switched to high-intensity settings with higher inspiratory pressures (IPAP at least 18 mbar, assist- controlled mode) and higher backup respiratory rate. Gro

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: COPD GOLD stage III-IV; naive for, but with an indication for NIV; clinically suspected or proven cardiac comorbidity; pH more than 7.35, signed informed consent; age more than 18.

Exclusion criteria

Exclusion criteria: Last hospitalisation for an exacerbation less than one month before inclusion; age under 18; deafness; mental retardation; inability to sign informed consent form

Design outcomes

Primary

Measure	Time frame
Left ventricular output during spontaneous breathing after 6 weeks of nocturnal noninvasive ventilation (Hi- or Low-NPPV) compared to the baseline left ventricualr output during spontaneous breathing. Left ventricular output is defined as stroke volume x heart rate. The stroke volume will be measured echocardiographically.	—

Secondary

Measure	Time frame
cardiac function under spontaneous breathing after 6 weeks of high or low-Intensity NPPV versus baseline measurements before NPPV: echocardiac measurements: Left ventricular ejection fraction (method of Simpson); Right ventricular Function and Tricuspidal annular plane excursion (TAPSE); Left ventricular output under NPPV; Systolic and Diastolic blood pressure; Systolic Pressure pulmonal artery; measurements under NPPV: Blood gas analysis; Transcutaneous CO2 monitoring; Respiratory muscle EMG; Breathing pattern analysis; lung function: Dyspnea sensation (BORG scale); 6-minute walking test in meter; Lung function testing (spirometry und lung volumes). quality of life: SRI Questionnaire	—

Measure

Time frame

cardiac function under spontaneous breathing after 6 weeks of high or low-Intensity NPPV versus baseline measurements before NPPV: echocardiac measurements: Left ventricular ejection fraction (method of Simpson); Right ventricular Function and Tricuspidal annular plane excursion (TAPSE); Left ventricular output under NPPV; Systolic and Diastolic blood pressure; Systolic Pressure pulmonal artery; measurements under NPPV: Blood gas analysis; Transcutaneous CO2 monitoring; Respiratory muscle EMG; Breathing pattern analysis; lung function: Dyspnea sensation (BORG scale); 6-minute walking test in meter; Lung function testing (spirometry und lung volumes). quality of life: SRI Questionnaire

—

Countries

Germany

Contacts

Public ContactWolfram Windisch

Lungenklinik Köln-MerheimKliniken der Stadt Köln gGmbH

windischw@kliniken-koeln.de+49-(0)221-8907-18929

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 10, 2026