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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal high flow

Group Type ACTIVE_COMPARATOR

Nasal high flow

Intervention Type DEVICE

3 sonographic measurements after use of 30 minutes

NIV

Group Type ACTIVE_COMPARATOR

NIV

Intervention Type DEVICE

3 sonographic measurements after 30 minutes use

Interventions

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Nasal high flow

3 sonographic measurements after use of 30 minutes

Intervention Type DEVICE

NIV

3 sonographic measurements after 30 minutes use

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No