Respiratory Insufficiency
Conditions
Keywords
nasal high flow, NIV, diaphragm, sonography
Brief 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)).
Interventions
DEVICENasal high flow
3 sonographic measurements after use of 30 minutes
DEVICENIV
3 sonographic measurements after 30 minutes use
Sponsors
University of Leipzig
Klinikum Emden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a randomised comparison of two investigational medical devices in a prospective, monocentric, randomised, physiological, open-label, cross-over study. Patients are randomised into two groups (study arms) with a randomisation ratio of 1:1.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | 30 min | Forced vital capacity in 1 second as % predicted |
| Tiffeneau - index | 30 min | FEV1%FVC in % = definition of obstruction of the airways |
| DEx | 30 minutes | Diaphragm excursion during rest |
| 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 \[calculation from the quotient of ΔTdi and Tdi,ee\]) |
| Respiratory rate | 30 min | counts the respiratory cycles in 1 minute |
Countries
Germany
Outcome results
None listed