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

Jens Bräunlich

Status: Unknown

Conditions: Diaphragm Issues; Respiratory Failure With Hypoxia; Non-invasive Mechanical Ventilation; Respiratory Failure With Hypercapnia

Treatments: Diagnostic Test: DTEI; Diagnostic Test: DTEE; Diagnostic Test: DEx

Study type: Interventional

Funder types: Other

Identifiers

NCT04962568

2

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

NHF-NIV

Experimental group

Description:

Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.

Treatment:

Diagnostic Test: DTEI

Diagnostic Test: DTEE

Diagnostic Test: DEx

NIV-NHF

Experimental group

Description:

Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.

Treatment:

Diagnostic Test: DTEI

Diagnostic Test: DTEE

Diagnostic Test: DEx