Back to resultsUltrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure (SENNI)
Primary Purpose
Diaphragm Issues, Respiratory Failure With Hypoxia, Respiratory Failure With Hypercapnia
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DTEE
DTEI
DEx
Sponsored by
About this trial
This is an interventional treatment trial for Diaphragm Issues
Eligibility Criteria
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
Sites / Locations
- University of LeipzigRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NHF-NIV
NIV-NHF
Arm Description
Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
Outcomes
Primary Outcome Measures
Changes in DTEE
Evaluation from baseline and between devices
Secondary Outcome Measures
Changes in DTEI
Evaluation from baseline and between devices
Changes in Dex
Evaluation from baseline and between devices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04962568
Brief Title
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
Acronym
SENNI
Official Title
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
August 7, 2021 (Actual)
Study Completion Date
September 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Bräunlich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Issues, Respiratory Failure With Hypoxia, Respiratory Failure With Hypercapnia, Non-invasive Mechanical Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NHF-NIV
Arm Type
Experimental
Arm Description
Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
Arm Title
NIV-NHF
Arm Type
Experimental
Arm Description
Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
Intervention Type
Diagnostic Test
Intervention Name(s)
DTEE
Intervention Description
endexpiratory diaphragm thickness in mm
Intervention Type
Diagnostic Test
Intervention Name(s)
DTEI
Intervention Description
endinspiratory diaphragm thickness in mm
Intervention Type
Diagnostic Test
Intervention Name(s)
DEx
Intervention Description
diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm
Primary Outcome Measure Information:
Title
Changes in DTEE
Description
Evaluation from baseline and between devices
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Changes in DTEI
Description
Evaluation from baseline and between devices
Time Frame
10 minutes
Title
Changes in Dex
Description
Evaluation from baseline and between devices
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Bräunlich, MD
Phone
494921981551
Email
highflow@web.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
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