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

• Sponsor: Jens Bräunlich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04962568
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diaphragm Issues; Respiratory Failure With Hypoxia; Respiratory Failure With Hypercapnia; Non-invasive Mechanical Ventilation	Diagnostic Test: DTEE; Diagnostic Test: DTEI; Diagnostic Test: DEx	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
• Actual Study Start Date: Jul 7, 2021
• Actual Primary Completion Date: Aug 7, 2021
• Anticipated Study Completion Date: Sep 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NHF-NIV Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.	Diagnostic Test: DTEE; endexpiratory diaphragm thickness in mm; Diagnostic Test: DTEI; endinspiratory diaphragm thickness in mm; Diagnostic Test: DEx; diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm
Experimental: NIV-NHF Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done.	Diagnostic Test: DTEE; endexpiratory diaphragm thickness in mm; Diagnostic Test: DTEI; endinspiratory diaphragm thickness in mm; Diagnostic Test: DEx; diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm

Outcome Measures

Primary Outcome Measures

1. Changes in DTEE [10 minutes]

   Evaluation from baseline and between devices

Secondary Outcome Measures

1. Changes in DTEI [10 minutes]

   Evaluation from baseline and between devices

2. Changes in Dex [10 minutes]

   Evaluation from baseline and between devices

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Leipzig	Leipzig		Germany

Sponsors and Collaborators

• Jens Bräunlich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jens Bräunlich, Sponsor and Investigator, Klinikum Emden
• ClinicalTrials.gov Identifier: NCT04962568
• Other Study ID Numbers: 2
• First Posted: Jul 15, 2021
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency; Hypoxia; Hypercapnia

Study Results

No Results Posted as of Mar 31, 2022