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

Anesthesia, Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240912
• Other study ID #: EESOA4
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: European e-Learning School in Obstetric Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy women in active labor who received epidural analgesia

Exclusion Criteria:

• healthy women in active labor who received ineffective epidural analgesia

Related Conditions & MeSH terms

• Anesthesia, Epidural

Intervention

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.

Locations

Country	Name	City	State
Italy	Città di Roma Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
European e-Learning School in Obstetric Anesthesia

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

Capogna G, Camorcia M, Coccoluto A, Micaglio M, Velardo M. Experimental validation of the CompuFlo® 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. — View Citation

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. — View Citation

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® Epidural Instrument. Anesthesiol Res Pract. 2019 Feb 3;2019:5185901. doi: 10.1155/2019/5185901. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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