Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Klinikum Emden
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Sonographic measurements of diaphragm thickness
Overview
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)).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Sonographic measurements of diaphragm thickness
Time Frame: 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)
- FEV1(30 min)
- Respiratory rate(30 min)
- Tiffeneau - index(30 min)
- Tdi pi(30 minutes)
- TF di(30 min)
Investigators
Jens Bräunlich
Clinical director, Head of department
Klinikum Emden