Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency (SENNI)

June 24, 2025 updated by: Jens Bräunlich, Klinikum Emden

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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, 04103
        • University of Leipzig

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nasal high flow
Device: Nasal high flow
3 sonographic measurements after use of 30 minutes
Active Comparator: NIV
Device: NIV
3 sonographic measurements after 30 minutes use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 30 minutes use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEx
Time Frame: 30 minutes
Diaphragm excursion during rest
30 minutes
FEV1
Time Frame: 30 min
Forced vital capacity in 1 second as % predicted
30 min
Tiffeneau - index
Time Frame: 30 min
FEV1%FVC in % = definition of obstruction of the airways
30 min
Respiratory rate
Time Frame: 30 min
counts the respiratory cycles in 1 minute
30 min
Tdi pi
Time Frame: 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
30 minutes
TF di
Time Frame: 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])
30 min

Collaborators and Investigators

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

Sponsor

Klinikum Emden

Collaborators

University of Leipzig

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 1, 2019

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

June 24, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 167/19-ek

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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