Clinical Trials Directory

Trials / Completed

CompletedNCT04432480

NIPE Monitoring Values During Routine Pediatric Anesthesia

Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

Summary

Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.

Conditions

Interventions

TypeNameDescription
PROCEDURENIPE (Newborn Infant Parasympathetic Evaluation) monitoringNon invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.

Timeline

Start date
2020-06-23
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2020-06-16
Last updated
2023-01-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04432480. Inclusion in this directory is not an endorsement.