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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedures with the use of device for LOR monitoring | Experimental | Patients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used. |
|
| Procedures without the use of device for LOR monitoring | No Intervention | Patients enrolled suffered from chronic back pain and underwent epidural infiltration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOR measurement via device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of resistance detection | A non invasive device to detect loss of resistance during epidural infiltration | throughout the epidural infiltration procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimiliano Carassiti, MD | University Campus Bio-Medico of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Bio Medico | Rome | RM | 00128 | Italy | ||
| University Hospital Campus BioMedico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28268312 | Background | 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. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:194-197. doi: 10.1109/EMBC.2016.7590673. | |
| 23419341 | Background |
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| Rome |
| 00128 |
| Italy |
| 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. |
| 27307290 | Background | 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. |
| 29068081 | Background | 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. |
| 29059983 | Background | 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. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:759-762. doi: 10.1109/EMBC.2017.8036935. |