NCT03672526: COMPUFLO

Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

Terminated NA Last updated 10 November 2022

What this trial tests

NA trial testing measure of injection pressure by compuflo in Locoregional Anesthesia in 105 participants. Terminated before completion.

Timeline

8 October 2018

Primary endpoint
24 January 2020

24 January 2020

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	105
Start date	8 October 2018
Primary completion	24 January 2020
Estimated completion	24 January 2020
Sites	1 location across France

Drugs / interventions tested

• measure of injection pressure by compuflo

Conditions studied

• Locoregional Anesthesia — all drugs for Locoregional Anesthesia →

Sponsor

University Hospital, Montpellier

Who can join

Under 16, any sex, with Locoregional Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Objective real-time epidural pressure measurement using the CompuFlo® device, a mono-center observational study.
   Hertz L, Sola C, Pico J, Aros J, et al · · 2025 · PMID 40318853 · DOI 10.1016/j.accpm.2025.101530