NIPE Monitoring Values During Routine Pediatric Anesthesia (OMNIPED)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Nociceptive Pain
• Intervention / Treatment: Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

• Study Contact: Name: Anne LAFFARGUE, MD; Phone Number: +33 03.20.44.57.41; Email: anne.laffargue@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children in the pediatric surgical wardof:

• Lille University hospital (Lille, France)
• Armand Trousseau Hospital (Paris, France)

Description

Inclusion Criteria:

• Surgery under general anesthesia
• Absence of analgesic treatment in the 24 hours before the intervention

Exclusion Criteria:

• Central or peripheral neuropathy
• Non sinus arrythmia, pace maker
• Cardiac surgery
• Analgesic medication within 24 hours before surgery
• Anti cholinergic or anti arrythmic chronic medication
• Opposition of the legal tutor or of the child

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children; 0-15 years old children undergoing surgery under general anesthesia	Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring; Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation of the instantaneous NIPE index after opioid administration	5 minutes after opioid administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the area under the ROC curve of NIPE value	the NIPE value is definied by the predictibility of a hemodynamic event : 20% increase in Baseline heart rate, blood pressure and NIPE values recorded just before skin incision	Baseline and 5 minutes before the first hemodynamic event.
Variation of the instantaneous NIPE index after skin incision		5 minutes after skin incision
Variation of the instantaneous NIPE index after insertion of airway control device		5 minutes after insertion of airway control device
Variation of the instantaneous NIPE index after removal of airway control device		5 minutes after removal of airway control device
Variation of the instantaneous NIPE index after anesthetic induction		5 minutes after anesthetic induction

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Fondation Apicil
• Investigators: Principal Investigator: Anne LAFFARGUE, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Monitoring; General anesthesia; Nociceptive Pain; Pediatric anesthesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain
• Other Study ID Numbers: 2019_31; 2020-A00059-30 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No