An interventional study of Nasal high flow and NIV in Respiratory Insufficiency, sponsored by Klinikum Emden. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Klinikum Emden · Not applicable, Interventional, and Treatment
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)).
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 35 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Klinikum Emden is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: Nasal high flow
Device: NIV
3 sonographic measurements after use of 30 minutes
3 sonographic measurements after 30 minutes use
Sonographic measurements of diaphragm thickness
Tdi ee in mm = Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum expiration
Time frame: after 30 minutes use
DEx
Diaphragm excursion during rest
Time frame: 30 minutes
FEV1
Forced vital capacity in 1 second as % predicted
Time frame: 30 min
Tiffeneau - index
FEV1%FVC in % = definition of obstruction of the airways
Time frame: 30 min
Respiratory rate
counts the respiratory cycles in 1 minute
Time frame: 30 min
Tdi pi
Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum inspiration (Tdi, pi) in mm
Time frame: 30 minutes
TF di
Thickening Fraction (calculated): TFdi Diaphragm thickening fraction (change in diaphragm thickness during inspiration as a percentage \[calculation from the quotient of ΔTdi and Tdi,ee\])
Time frame: 30 min
Plan to share: Yes — All data upon request
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Klinikum Emden