https://orcid.org/0000-0002-1643-7886
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Abstract
Background
The epidural pressure is pulsatile and synchronized with arterial pulsations. Monitoring the epidural waveform has been suggested as a technique to reliably confirm the appropriate localization of the epidural catheter.
Objective
The aim of this study was to evaluate the sensitivity and specificity of the Computer Controlled Drug Delivery System with continuous pressure and waveform sensing technology (CCDDS) (CompuFlo® CathCheck™) as an instrument to assess the correct placement of the catheter in the epidural space in parturients who have received combined spinal-epidural technique (CSE) for labor analgesia.
Methods
We enrolled 40 consecutive healthy patients undergoing CSE labor analgesia with successful analgesia. All the cases in which pulsatile waveforms in synchrony with heart rate were detected were considered to be true positives; all the cases in which there was the absence of pulsatile waves were followed up. If these patients had to eventually relocate or manipulate the epidural catheter, they were considered to be true negative. If the absence of pulse waves was observed in the presence of successful analgesia during labor, the patients were considered to be false negatives.
Results
Pulsatile waveforms synchronous with heart rate were observed in 33 cases associated with adequate analgesia. In 5 cases, the pulsatile waveforms were absent due to unilateral analgesia or catheter occlusion (true negatives). In 2 cases, the patients had effective analgesia but we were not able to observe a distinct pulsatile waveform. The pressure waveform analysis through the epidural catheter had a sensitivity of 95%, a positive predictive value of 100%, a specificity of 100% and a negative predictive value of 60%.
Conclusion
Pulsatile pressure waveform recording with CCDDS through the epidural catheter resulted in high sensitivity and positive predictive value which can help the proper placement of the epidural catheter.
Data Sharing Statement
The data that support the findings of this study are available from EESOA(,) however, they are not publicly available. Deidentified data are available from the corresponding author (Prof Giorgio Capogna, email: [email protected]) upon reasonable request.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; they took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and have agreed to be accountable for all aspects of the work.
Disclosure
GC is a member of the Scientific Advisory for Milestone Inc. MH is Director, Scientific Affairs, Milestone Inc. MH also has a patent UPTO #10646660 with royalties paid to Milestone Scientific, Inc. The authors report no other conflicts of interest in this work.