Clinical Trials Directory

Trials / Terminated

TerminatedNCT03672526

Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
105 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

The purpose of this study is to evaluate the usual practice using Compuflo, allowing the continuous measurement of the injection pressure of the local anesthetic at the needle level. On the day of the surgery, an anesthesiologist "operator" will realize the echo-guided regional anesthesia, qualifying aloud every injection realized (site or compartment of injection, and volume injected). An "observer" anesthesiologist will note the demographic data (age and weight), then the material data (minimum stimulation intensity, type and size of needles and syringes used), and finally he will note the maximum pressure levels reached during the injections performed.

Conditions

Interventions

TypeNameDescription
DEVICEmeasure of injection pressure by compufloinjection pressure mesured by Compuflo

Timeline

Start date
2018-10-08
Primary completion
2020-01-24
Completion
2020-01-24
First posted
2018-09-14
Last updated
2022-11-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03672526. Inclusion in this directory is not an endorsement.