New Mechatronic Device for Epidural Space Detection

Non Invasive Monitoring of Loss of Resistance During Epidural Injection Clinical Trial

Official title:

A New Pressure Guided Mechatronic Tool for Epidural Space Detection: Feasibility Assessment in a Clinical Scenario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589391
• Other study ID #: EPISENS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: July 2018
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 4, 2018
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients whose pathology requires specific treatment such as epidural infiltration

Exclusion Criteria:

• coagulation abnormalities or assumption of anticoagulant drugs

Related Conditions & MeSH terms

• Non Invasive Monitoring of Loss of Resistance During Epidural Injection

Intervention

Device:
• LOR measurement via device
The epidural technique is totally performed in a sterile field without any harm to the patient. The LOR measurement is monitored via the bespoke device used during the epidural procedure.

Locations

Country	Name	City	State
Italy	Campus Bio Medico	Rome	RM
Italy	University Hospital Campus BioMedico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Carassiti M, Biselli V, Cecchini S, Zanzonico R, Schena E, Silvestri S, Cataldo R. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal airway: an in vivo study. Minerva Anestesiol. 2013 May;79(5):515-24. Epub 2013 Feb 18. — View Citation

Carassiti M, Mattei A, Pizzo CM, Vallone N, Saccomandi P, Schena E. Bronchial blockers under pressure: in vitro model and ex vivo model. Br J Anaesth. 2016 Sep;117 Suppl 1:i92-i96. doi: 10.1093/bja/aew120. Epub 2016 Jun 14. — View Citation

Carassiti M, Mattei A, Quarta R, Massaroni C, Saccomandi P, Tesei M, Setola R, Schena E. A New Pressure Guided Management Tool for Epidural Space Detection: Feasibility Assessment on a Simulator. Artif Organs. 2017 Dec;41(12):E320-E325. doi: 10.1111/aor.13007. Epub 2017 Oct 25. — View Citation

Carassiti M, Quarta R, Mattei A, Tesei M, Saccomandi P, Massaroni C, Setola R, Schena E. Ex vivo animal-model assessment of a non-invasive system for loss of resistance detection during epidural blockade. Conf Proc IEEE Eng Med Biol Soc. 2017 Jul;2017:759-762. doi: 10.1109/EMBC.2017.8036935. — View Citation

Tesei M, Saccomandi P, Massaroni C, Quarta R, Carassiti M, Schena E, Setola R. A cost-effective, non-invasive system for pressure monitoring during epidural needle insertion: Design, development and bench tests. Conf Proc IEEE Eng Med Biol Soc. 2016 Aug;2016:194-197. doi: 10.1109/EMBC.2016.7590673. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of resistance detection	A non invasive device to detect loss of resistance during epidural infiltration	throughout the epidural infiltration procedure