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

NCT07050147 | Completed

• 1 other identifier: 167/19-ek
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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)).

Conditions

Respiratory Insufficiency

Keywords

nasal high flow; NIV; diaphragm; sonography

Outcome Measures

Primary Outcomes (1)

• Sonographic measurements of diaphragm thickness

  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 Outcomes (6)

• DEx

  30 minutes

• FEV1

  30 min

• Tiffeneau - index

  30 min

• Respiratory rate

  30 min

• Tdi pi

  30 minutes

Study Arms (2)

Nasal high flow

ACTIVE COMPARATOR

Device: Nasal high flow

NIV

ACTIVE COMPARATOR

Device: NIV

Interventions

Nasal high flow DEVICE

3 sonographic measurements after use of 30 minutes

Nasal high flow

NIV DEVICE

3 sonographic measurements after 30 minutes use

NIV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• acute or chronic respiratory insufficiency with and/or hypercapnia,
• age \> 18 years.
• tolerate respiratory support devices
• to sign a written declaration of consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Emden: lead
• University of Leipzig: collaborator

Study Sites (1)

University of Leipzig

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director, Head of department

Model Details: This study is a randomised comparison of two investigational medical devices in a prospective, monocentric, randomised, physiological, open-label, cross-over study. Patients are randomised into two groups (study arms) with a randomisation ratio of 1:1.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: July 3, 2025
• Study Start: July 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)