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

Klinikum Emden

Status: Completed

Conditions: Respiratory Insufficiency

Treatments: Device: Nasal high flow; Device: NIV

Study type: Interventional

Funder types: Other

Identifiers

NCT07050147

167/19-ek

Details and patient eligibility

About

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)).

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute or chronic respiratory insufficiency with and/or hypercapnia,
• age > 18 years.
• tolerate respiratory support devices
• to sign a written declaration of consent

Exclusion criteria

• Presence of respiratory insufficiency requiring intubation,
• clinical instability,
• metabolic acidosis or alkalosis,
• Contraindication for NIV according to the S3 guideline,
• serious concomitant illnesses,
• unwillingness to co-operate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Nasal high flow

Active Comparator group

Treatment:

Device: Nasal high flow

NIV

Active Comparator group

Treatment:

Device: NIV