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High-Pressure NIV with moderate backup-frequency and expiratory ramp – a prospective observational study

High-Pressure NIV with moderate backup-frequency and expiratory ramp – a prospective observational study - HP-NIV-MER

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038593
Enrollment
110
Registered
2025-11-28
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

J44

Interventions

Group 1: The study aims to demonstrate the effectiveness of HP-NIV-MER based on the analysis of retrospective and prospective routine data. Patients with COPD are treated with HP-NIV-MER at our hospit

Sponsors

Thoraxklinik Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Chronic obstructive pulmonary disease Chronic hypercapnic respiratory failure HP-NIV-MER

Exclusion criteria

Exclusion criteria: Lung and thoracic diseases others than COPD Severe obesity (BMI greater than 35 kg/m2) Severe heart failure, unstable angina, or severe arrhythmias Malignant underlying or concomitant disease Inability to attend the first follow-up after approximately 3 months Acute hypercapnia with acidosis and/or aeCOPD

Design outcomes

Primary

MeasureTime frame
?pCO2 of patients at the first follow-up after approximately 3 months (compared to pCO2 at NIV-initiation)

Secondary

MeasureTime frame
?S3-NIV at the first follow-up after approximately 3 months (compared to the S3-NIV after initial initiation) S3 NIV on the day of discharge after NIV-initiation Average respiratory rate after NIV-initiation Reported side effects at the first follow-up examination after approx. 3 months Average usage time at the first follow-up examination after approx. 3 months Therapy discontinuations at the first follow-up examination after approx. 3 months Ventilation settings at discharge after NIV-initiation Detect predictors of success and failure of HP NIV-MER, if statistically meaningful Average respiratory rate at the first follow-up examination after approximately 3 months Air leaks at the first follow-up examination after approximately 3 months

Countries

Germany

Contacts

Public ContactBenjamin Neetz

Thoraxklinik Heidelberg

benjamin.neetz@med.uni-heidelberg.de062213968910

Outcome results

None listed

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