Ultrasonographic Evaluation of the Diaphragm During NHF V... | NCT04962568

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

NCT04962568

Sponsor

Jens Bräunlich

Status

Unknown status

Last Update Posted

Mar 31, 2022Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

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

Interventions

DTEE
DTEI
DEx

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Aug 7, 2021Actual

Completion Date

Sep 5, 2022Estimated

First Submitted Date

Jul 5, 2021

First Submission Date that Met QC Criteria

Jul 5, 2021

First Posted Date

Jul 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NHF-NIV	Experimental	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.	Diagnostic Test: DTEE Diagnostic Test: DTEI Diagnostic Test: DEx
NIV-NHF	Experimental	Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.	Diagnostic Test: DTEE Diagnostic Test: DTEI Diagnostic Test: DEx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DTEE	Diagnostic Test	endexpiratory diaphragm thickness in mm	NHF-NIV NIV-NHF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in DTEE	Evaluation from baseline and between devices	10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Changes in DTEI	Evaluation from baseline and between devices	10 minutes
Changes in Dex	Evaluation from baseline and between devices

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig	Recruiting	Leipzig			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided