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Epidural Waveforms: Pressure Transducer vs CompuFlo

Not Applicable
Completed
Conditions
Anesthesia
Interventions
Device: CompuFlo
Registration Number
NCT04240197
Lead Sponsor
European e-Learning School in Obstetric Anesthesia
Brief Summary

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.

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • patients with an epidural lumbar catheter for anesthesia or analgesia
Exclusion Criteria
  • patients with malfunction or dislodgement of the epidural catheter

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
CompuFloCompuFloEpidural pressure waveforms will be measured by using the CompuFlo Instrument
Standard Pressure TransducerCompuFloEpidural pressure waveforms will be measured by using a standard invasive monitor pressure transducer
Primary Outcome Measures
NameTimeMethod
Pulse Waveup to 15 minutes

Occurrence of epidural pulse wave

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Città di Roma Hospital

🇮🇹

Roma, Italy

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