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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00059-30 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children | 0-15 years old children undergoing surgery under general anesthesia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIPE (Newborn Infant Parasympathetic Evaluation) monitoring | Procedure | Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the instantaneous NIPE index after opioid administration | 5 minutes after opioid administration |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children in the pediatric surgical wardof:
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| Name | Affiliation | Role |
|---|---|---|
| Anne LAFFARGUE, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Jeanne de Flandre Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |