NIPE Monitoring Values During Routine Pediatric Anesthesia

Anesthesia Clinical Trial

— OMNIPED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432480
• Other study ID #: 2019_31
• Secondary ID: 2020-A00059-30
• Status: Completed
• Start date: June 23, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Nociceptive Pain

Intervention

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.

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the instantaneous NIPE index after opioid administration		5 minutes after opioid administration
Secondary	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.
Secondary	Variation of the instantaneous NIPE index after skin incision		5 minutes after skin incision
Secondary	Variation of the instantaneous NIPE index after insertion of airway control device		5 minutes after insertion of airway control device
Secondary	Variation of the instantaneous NIPE index after removal of airway control device		5 minutes after removal of airway control device
Secondary	Variation of the instantaneous NIPE index after anesthetic induction		5 minutes after anesthetic induction