Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System

Completed

• Conditions: Anesthesia, Epidural

• Registration Number: NCT04240912
• Lead Sponsor: European e-Learning School in Obstetric Anesthesia

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)

Primary end points:

1. appearance and recording of EPW by using the CompuFlo instrument.

2. absence of EPW in case of inadequate analgesia, intravascular placement or unilateral analgesia 3) successful analgesia, defined as the occurrence of a visual analogue pain score less than 10/100 during the study period

Secondary end points:

* time from the last epidural bolus and the EPW recordings

* EPW recordings between uterine contractions and at the apex of a uterine contraction

* EPW recordings when the patient is supine or in left lateral decubitus

* EPW recordings during 10 sec Valsalva maneuver

* priming volume of saline necessary to detect EPW (5,10,15,20 ml)

Tertiary end points:

* epidural actual pressure (mmHg)

* EPW disappearance or absence during catheter removal or during ineffective analgesia

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-04-28
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• healthy women in active labor who received epidural analgesia

Exclusion Criteria

• healthy women in active labor who received ineffective epidural analgesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurrence of epidural pulse waves (EPW)	up to 5 minutes	The occurrence of EPW recorded by the CompuFlo in working epidural catheters (epidural catheter which have produced epidural block)

Secondary Outcome Measures

Name	Time	Method
patient position	up to 10 minutes	Whether patients' position (sitting or left lateral decubitus) affects the presence/absence of epidural pulse wave and/or its amplitude
uterine contractions	up to 10 minutes	Whether the presence/absence of epidural pulse wave and/or its amplitude changes during uterine contraction in laboring women
valsalva	up to 10 minutes	Whether the presence/absence of epidural pulse wave and/or its amplitude changes during the Valsava maneuvre in laboring women

Trial Locations

Locations (1)

Città di Roma Hospital; 🇮🇹 Rome, Italy