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The purpose of this single arm, open label study will be to compare and evaluate the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space when compared to the standard pressure transducer.
40 patients who had an epidural functioning catheter previously positioned for anesthesia or analgesia will be enrolled. After removing the epidural filter and after having zeroed the instrument, the investigator will connect in a random fashion sequence, a standard pressure transducer attached to a standard invasive blood pressure monitor or to the CompuFlo CathCheck instrument to observe and record the occurrence of epidural pulsatile waveform.
The investigator will also note and evaluate:
The volume of saline priming necessary to obtain the waveform The effects of patient's position on the occurrence and amplitude of epidural pulsatile waveform
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pressure Transducer | Sham Comparator | Epidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer |
|
| CompuFlo | Active Comparator | Epidural pressure waveforms will be measured by using the CompuFlo Instrument |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CompuFlo | Device | The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave | Occurrence of epidural pulse wave | up to 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giorgio Capogna, MD | European e-Learning School in Obstetric Anesthesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Città di Roma Hospital | Roma | 00151 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30482001 | Background | Hilber ND, Rijs K, Klimek M, Saenz G, Aloweidi A, Rossaint R, Heesen M. A systematic review of the diagnostic accuracy of epidural wave form analysis to identify the epidural space in surgical and labor patients. Minerva Anestesiol. 2019 Apr;85(4):393-400. doi: 10.23736/S0375-9393.18.13089-6. Epub 2018 Nov 22. |
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