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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Epidural
• Intervention / Treatment: Device: CompuFlo Epidural Computer Controlled System

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Citta di Roma Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

healthy women in active labor who received epidural analgesia

Description

Inclusion Criteria:

• healthy women in active labor who received epidural analgesia

Exclusion Criteria:

• healthy women in active labor who received ineffective epidural analgesia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: European e-Learning School in Obstetric Anesthesia

Publications and helpful links

General Publications

• Capogna G, Camorcia M, Coccoluto A, Micaglio M, Velardo M. Experimental validation of the CompuFlo(R) epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. Int J Obstet Anesth. 2018 Nov;36:28-33. doi: 10.1016/j.ijoa.2018.04.008. Epub 2018 May 4.
• Vaira P, Camorcia M, Palladino T, Velardo M, Capogna G. Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo(R) Epidural Instrument. Anesthesiol Res Pract. 2019 Feb 3;2019:5185901. doi: 10.1155/2019/5185901. eCollection 2019.
• Gebhard RE, Moeller-Bertram T, Dobecki D, Peralta F, Pivalizza EG, Rupasinghe M, Ilic S, Hochman M. Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology: A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance. Anesth Analg. 2019 Nov;129(5):1319-1327. doi: 10.1213/ANE.0000000000003873.
• Al-Aamri I, Derzi SH, Moore A, Elgueta MF, Moustafa M, Schricker T, Tran DQ. Reliability of pressure waveform analysis to determine correct epidural needle placement in labouring women. Anaesthesia. 2017 Jul;72(7):840-844. doi: 10.1111/anae.13872. Epub 2017 Apr 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2020
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Epidural labor analgesia; Epidural catheter assessment
• Other Study ID Numbers: EESOA4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes