Monitoring of Injection Pressure During Regional Anesthes... | NCT03672526

Studies
Monitoring of Injection Pressure During Regional Anesthesia in Pediatric Patient

NCT03672526

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Nov 10, 2022Actual

Enrollment

105Actual

Phase

Not Applicable

Conditions

Locoregional Anesthesia

Interventions

measure of injection pressure by compuflo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

decision of the principal investigator

Expanded Access Info

Start Date

Oct 8, 2018Actual

Primary Completion Date

Jan 24, 2020Actual

Completion Date

Jan 24, 2020Actual

First Submitted Date

Sep 11, 2018

First Submission Date that Met QC Criteria

Sep 11, 2018

First Posted Date

Sep 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2022

Last Update Posted Date

Nov 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
device compuflo	Experimental		Device: measure of injection pressure by compuflo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measure of injection pressure by compuflo	Device	injection pressure mesured by Compuflo	device compuflo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
injection pressure (injection pressure measured by Compuflo)	injection pressure measured by Compuflo	up to 24 hours (during the ALR)

Secondary Outcomes

Measure	Description	Time Frame
Pressure values compared to the threshold value used in adults of 15 Psi	Pressure values compared to the threshold value used in adults of 15 Psi	up to 24 hours (during the ALR)
Pressure values according to the different types of material used

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minor patient (0-16 years old) with consent of the major legal representative
Affiliated to the social security
Informed written consent, notification on the anesthesia sheet

Exclusion Criteria:

Patient over 16 years old
Patient under tutorship / curatorship
Young girl with known or suspected ongoing pregnancy
Known allergy to local anesthetics
Hemostatic disorder
Local infection at the puncture site

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Montpellier		Montpellier		34380	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41532315	Derived	Hertz L, Sola C, Pico J, Scott C, Choquet O, Pirat P, Saour AC, Bringuier S, Dadure C. Objective Real-Time Peripheral Regional Anesthesia Pressure Measurement in Children Using the CompuFlo Device, a Mono-Center Observational Study. Paediatr Anaesth. 2026 Apr;36(4):412-420. doi: 10.1002/pan.70113. Epub 2026 Jan 14.
40318853	Derived