Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System
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|ClinicalTrials.gov Identifier: NCT04240912|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 5, 2020
|Condition or disease||Intervention/treatment|
|Anesthesia, Epidural||Device: CompuFlo Epidural Computer Controlled System|
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:
- appearance and recording of EPW by using the CompuFlo instrument.
- 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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo® Cath-Checker System in Laboring Women.|
|Actual Study Start Date :||April 28, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
- Device: CompuFlo Epidural Computer Controlled System
The CompuFlo Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the physician to perform epidural anesthesia and epidural injections using standard methods. However, for the purpose of this study the instrument will be used only as a monitor to detect the occurrence of EPW.
The CompuFlo Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017.
- 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)
- patient position [ Time Frame: 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 [ Time Frame: up to 10 minutes ]Whether the presence/absence of epidural pulse wave and/or its amplitude changes during uterine contraction in laboring women
- valsalva [ Time Frame: up to 10 minutes ]Whether the presence/absence of epidural pulse wave and/or its amplitude changes during the Valsava maneuvre in laboring women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240912
|Contact: Giorgio Capogna, MD||+39 06 email@example.com|
|Città di Roma Hospital||Recruiting|
|Contact: Michela Camorcia, MD|
|Study Director:||Giorgio Capogna, MD||European e-Learning School in Obstetric Anesthesia|