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NCT04962568 Clinical Trial

Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure

Diaphragm Issues Clinical Trial

— SENNI  

Official title:
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04962568
Other study ID # 2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date September 5, 2022

Study information
Verified date March 2022
Source Klinikum Emden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated.

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date September 5, 2022
Est. primary completion date August 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - acute or chronic respiratory failure, hyperemic or hypercapnic - age > 18 yrs - written consent Exclusion Criteria: - critical disease (intubation, heart failure, lung edema,..) - no compliance - metabolic acidosis

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DTEE
endexpiratory diaphragm thickness in mm
• DTEI
endinspiratory diaphragm thickness in mm
• DEx
diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm

Locations
Country Name City State
Germany University of Leipzig Leipzig

Sponsors (1)
Lead Sponsor Collaborator
Jens Bräunlich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in DTEE Evaluation from baseline and between devices 10 minutes
Secondary Changes in DTEI Evaluation from baseline and between devices 10 minutes
Secondary Changes in Dex Evaluation from baseline and between devices 10 minutes
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