NCT07050147

Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Klinikum Emden · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the influence of respiratory support on diaphragmatic function (O2, NHF, NIV). The effects on the diaphragm, the respiratory values (FEV1, respiratory rate) and the subjective well-being of the patients during the therapy phases will be measured. The primary objective of the clinical study is to investigate the differences in respiratory support with regard to the change in diaphragmatic kinetics and morphology (Tdi; TEx; Tdi, ee, Tdi, pi, ΔTdi, TFdi) as a function of respiratory rate. For both ventilation modes, the influence on the respiratory situation, the respiratory muscle pump and adverse events will also be analysed. This is done using defined variables (FEV1, FEV1%VC, respiratory rate, frequency and type of adverse events (AEs), subjective satisfaction with the test product (Borg scale)).

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	Nasal high flow	3 sonographic measurements after use of 30 minutes
DEVICE	NIV	3 sonographic measurements after 30 minutes use

Timeline

• Start date: 2019-07-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Germany