Telemonitoring for outpatient follow-up care of patients with non-invasive ventilation at home

Telemonitoring for outpatient follow-up care of patients with non-invasive ventilation at home - TOFNI

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036966

Enrollment

Registered

2025-10-15

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

J96.11

Interventions

Group 1: •Mobile arterial blood gas analysis (ABG): Outpatient measurement of pH, pCO2, pO2, HCO3?, and other parameters to assess the respiratory status. •Telemonitoring (recording of ventilation par

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with established non-invasive ventilation (NIV) therapy for at least three months due to type 2 respiratory failure Presence of capacity to consent as well as signed data protection and informed consent documents

Exclusion criteria

Exclusion criteria: Age under 18 years Presence of deafness Lack of capacity to consent without legal guardianship

Design outcomes

Primary

Measure	Time frame
Change in quality of life based on the SRI score (comparison t0 vs. t12); t0 = baseline visit; t12 = final visit after 12 months	—

Secondary

Measure	Time frame
•Descriptive analysis of demographic characteristics and care situation •Assessment of ventilation quality •Recording of hospitalization rate •Evaluation of therapy adherence (compliance) •Determination of exacerbation rate (moderate and severe) over time (t0 vs. t12) •Assessment of patient satisfaction using standardized questionnaires	—

Countries

Germany

Contacts

Public ContactSarah Bettina Stanzel

Kliniken der Stadt Köln, Abteilung für Pulmologie

stanzels@kliniken-koeln.de0221890718337

Outcome results

None listed

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