NCT04962568

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

July 5, 2021

Last Update Submit

March 29, 2022

Conditions

Diaphragm IssuesRespiratory Failure With HypoxiaRespiratory Failure With HypercapniaNon-invasive Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Changes in DTEE

    Evaluation from baseline and between devices

    10 minutes

Secondary Outcomes (2)

  • Changes in DTEI

    10 minutes

  • Changes in Dex

    10 minutes

Study Arms (2)

NHF-NIV

EXPERIMENTAL

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

Diagnostic Test: DTEEDiagnostic Test: DTEIDiagnostic 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: DTEEDiagnostic Test: DTEIDiagnostic Test: DEx

Interventions

DTEEDIAGNOSTIC_TEST

endexpiratory diaphragm thickness in mm

NHF-NIVNIV-NHF
DTEIDIAGNOSTIC_TEST

endinspiratory diaphragm thickness in mm

NHF-NIVNIV-NHF
DExDIAGNOSTIC_TEST

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

NHF-NIVNIV-NHF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute or chronic respiratory failure, hyperemic or hypercapnic
  • age \> 18 yrs
  • written consent

You may not qualify if:

  • critical disease (intubation, heart failure, lung edema,..)
  • no compliance
  • metabolic acidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig

Leipzig, Germany

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor and Investigator

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 15, 2021

Study Start

July 7, 2021

Primary Completion

August 7, 2021

Study Completion

September 5, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

DE(1)