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Completed

NCT Number: NCT07050147

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

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)).

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal High Flow

Device

3 sonographic measurements after use of 30 minutes

NIV

Device

3 sonographic measurements after 30 minutes use

Primary outcomes

  1. 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

  1. DEx

    Time frame: 30 minutes

    Diaphragm excursion during rest

  2. FEV1

    Time frame: 30 min

    Forced vital capacity in 1 second as % predicted

  3. Tiffeneau - index

    Time frame: 30 min

    FEV1%FVC in % = definition of obstruction of the airways

  4. Respiratory rate

    Time frame: 30 min

    counts the respiratory cycles in 1 minute

  5. 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

  6. 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])

Sponsors and collaborators

Lead sponsor

Klinikum Emden

Other

Collaborators

  • University of Leipzig

Registry information

Acronym: SENNI

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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