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

NCT07050147 — Not applicable, Completed, 35 participants, Klinikum Emden

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Registry	NCT07050147, acronym SENNI
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	35 (Actual)
Sponsor	Klinikum Emden (Other); collaborators: University of Leipzig
Conditions	Respiratory Insufficiency
Interventions	Nasal high flow, NIV (Device)
Dates	start 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 in Germany

-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)).

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+Arms and interventions

Arm	Type	Interventions	Description
Nasal high flow	Active comparator	Device: Nasal high flow
NIV	Active comparator	Device: NIV

Nasal high flow (Device): 3 sonographic measurements after use of 30 minutes
NIV (Device): 3 sonographic measurements after 30 minutes use

+Outcome measures

Primary outcomes

Sonographic measurements of diaphragm thickness [after 30 minutes use]: Tdi ee in mm = Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum expiration

Secondary outcomes

DEx [30 minutes]: Diaphragm excursion during rest
FEV1 [30 min]: Forced vital capacity in 1 second as % predicted
Tiffeneau - index [30 min]: FEV1%FVC in % = definition of obstruction of the airways
Respiratory rate [30 min]: counts the respiratory cycles in 1 minute
Tdi pi [30 minutes]: Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum inspiration (Tdi, pi) in mm
TF di [30 min]: Thickening Fraction (calculated): TFdi Diaphragm thickening fraction (change in diaphragm thickness during inspiration as a percentage \[calculation from the quotient of ΔTdi and Tdi,ee\])

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
University of Leipzig	Leipzig	Germany