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Clinical Trials/NCT04240912
NCT04240912CompletedNot Applicable

Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.

European e-Learning School in Obstetric Anesthesia1 site in 1 country40 target enrollmentStarted: April 28, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
occurrence of epidural pulse waves (EPW)

Study Overview

Brief Summary

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

Detailed Description

The purpose of this single arm, open label study will be to evaluate whether the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter may affect the sensitivity and specificity of CompuFlo to detect epidural pulse waveforms (EPW) to assess the correct placement of the catheter in the epidural space.

The primary objective will be the correlation between the appearance of EPW recorded by the CompuFlo and the correct placement of the epidural catheter as assessed by the occurrence of adequate bilateral labor analgesia.

Secondary objectives will be the effects of the dwell time of the epidural catheter, patients' position, the presence of active labor contractions and the priming volume of the epidural catheter on the EPW.

The study will enroll consecutive parturients in active labor who have received effective epidural labor analgesia with an epidural catheter. After epidural catheter priming, the occurrence or the absence of EPW will be investigated.

Endpoints (quantitative measurements required by the objectives)

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • healthy women in active labor who received epidural analgesia

Exclusion Criteria

  • healthy women in active labor who received ineffective epidural analgesia

Outcomes

Primary Outcomes

occurrence of epidural pulse waves (EPW)

Time Frame: up to 5 minutes

The occurrence of EPW recorded by the CompuFlo in working epidural catheters (epidural catheter which have produced epidural block)

Secondary Outcomes

  • patient position(up to 10 minutes)
  • uterine contractions(up to 10 minutes)
  • valsalva(up to 10 minutes)

Investigators

Sponsor
European e-Learning School in Obstetric Anesthesia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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