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

NCT07050147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-03

No results posted yet for this study

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

DEVICE

Nasal high flow

3 sonographic measurements after use of 30 minutes

DEVICE

NIV

3 sonographic measurements after 30 minutes use

Sponsors & Collaborators

  • University of Leipzig

    collaborator OTHER

  • Klinikum Emden

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050147 on ClinicalTrials.gov