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

NCT ID: NCT04962568

Last Updated: 2022-03-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2022-09-05

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NHF-NIV

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

Group Type EXPERIMENTAL

DTEE

Intervention Type DIAGNOSTIC_TEST

endexpiratory diaphragm thickness in mm

DTEI

Intervention Type DIAGNOSTIC_TEST

endinspiratory diaphragm thickness in mm

DEx

Intervention Type DIAGNOSTIC_TEST

diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm

NIV-NHF

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

Group Type EXPERIMENTAL

DTEE

Intervention Type DIAGNOSTIC_TEST

endexpiratory diaphragm thickness in mm

DTEI

Intervention Type DIAGNOSTIC_TEST

endinspiratory diaphragm thickness in mm

DEx

Intervention Type DIAGNOSTIC_TEST

diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm

Interventions

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DTEE

endexpiratory diaphragm thickness in mm

Intervention Type DIAGNOSTIC_TEST

DTEI

endinspiratory diaphragm thickness in mm

Intervention Type DIAGNOSTIC_TEST

DEx

diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jens Bräunlich

OTHER

Sponsor Role lead

Responsible Party

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Jens Bräunlich

Sponsor and Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Leipzig

Leipzig, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Jens Bräunlich, MD

Role: primary

494921981551

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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