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

March 29, 2022 updated by: Jens Bräunlich
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany
        • Recruiting
        • University of Leipzig
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NHF-NIV
Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
Diagnostic test: DTEE
endexpiratory diaphragm thickness in mm
Diagnostic test: DTEI
endinspiratory diaphragm thickness in mm
Diagnostic test: DEx
diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm
Experimental: NIV-NHF
Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
Diagnostic test: DTEE
endexpiratory diaphragm thickness in mm
Diagnostic test: DTEI
endinspiratory diaphragm thickness in mm
Diagnostic test: DEx
diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in DTEE
Time Frame: 10 minutes
Evaluation from baseline and between devices
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in DTEI
Time Frame: 10 minutes
Evaluation from baseline and between devices
10 minutes
Changes in Dex
Time Frame: 10 minutes
Evaluation from baseline and between devices
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Bräunlich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

August 7, 2021

Study Completion (Anticipated)

September 5, 2022

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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