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

Not Applicable

• Conditions: Diaphragm Issues; Respiratory Failure With Hypoxia; Respiratory Failure With Hypercapnia; Non-invasive Mechanical Ventilation
• Interventions: Diagnostic Test: DTEE; Diagnostic Test: DTEI; Diagnostic Test: DEx

• Registration Number: NCT04962568
• Lead Sponsor: Jens Bräunlich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study Start: 2021-07-07
• Study First Posted: 2021-07-15
• Primary Completion: 2021-08-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Study Completion: 2022-09-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NHF-NIV	DEx	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
NIV-NHF	DTEI	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
NHF-NIV	DTEI	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
NHF-NIV	DTEE	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
NIV-NHF	DTEE	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.
NIV-NHF	DEx	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.

Primary Outcome Measures

Name	Time	Method
Changes in DTEE	10 minutes	Evaluation from baseline and between devices

Secondary Outcome Measures

Name	Time	Method
Changes in DTEI	10 minutes	Evaluation from baseline and between devices
Changes in Dex	10 minutes	Evaluation from baseline and between devices

Trial Locations

Locations (1)

University of Leipzig; 🇩🇪 Leipzig, Germany