AnesthesiaOMNIPEDNCT04432480
NIPE Monitoring Values During Routine Pediatric Anesthesia
An observational study of Anesthesia and Nociceptive Pain, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Anesthesia, Nociceptive Pain
- What is being tested?
- NIPE (Newborn Infant Parasympathetic Evaluation) monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children in the pediatric surgical wardof: * Lille University hospital (Lille, France) * Armand Trousseau Hospital (Paris, France)
Who may be able to join
- Surgery under general anesthesia
- Absence of analgesic treatment in the 24 hours before the intervention
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia, Nociceptive Pain
- Being tested
- NIPE (Newborn Infant Parasympathetic Evaluation) monitoring
- Keywords
- General anesthesia, Nociceptive Pain, Monitoring, Pediatric anesthesia
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPE (Newborn Infant Parasympathetic Evaluation) monitoringProcedure or surgery
Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Children | 0-15 years old children undergoing surgery under general anesthesia Receives: Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the instantaneous NIPE index after opioid administration
Measured: 5 minutes after opioid administration
Secondary outcomes (5)
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
Measured: Baseline and 5 minutes before the first hemodynamic event.
Variation of the instantaneous NIPE index after skin incision
Measured: 5 minutes after skin incision
Variation of the instantaneous NIPE index after insertion of airway control device
Measured: 5 minutes after insertion of airway control device
Variation of the instantaneous NIPE index after removal of airway control device
Measured: 5 minutes after removal of airway control device
Variation of the instantaneous NIPE index after anesthetic induction
Measured: 5 minutes after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start23 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Anne LAFFARGUE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432480
- Sponsor's protocol ID
- 2019_31
- Other IDs
- 2020-A00059-30
- Acronym
- OMNIPED
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT04432480
- Acronym / sponsor ID
- OMNIPED / 2019_31
- Conditions
- Anesthesia, Nociceptive Pain
- Keywords
- General anesthesia, Nociceptive Pain, Monitoring, Pediatric anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | Procedure: NIPE (Newborn Infant Parasympathetic Evaluation) monitoring0-15 years old children undergoing surgery under general anesthesia |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children in the pediatric surgical wardof: * Lille University hospital (Lille, France) * Armand Trousseau Hospital (Paris, France)
Key inclusion criteria (2 listed)
- Surgery under general anesthesia
- Absence of analgesic treatment in the 24 hours before the intervention
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIPE (Newborn Infant Parasympathetic Evaluation) monitoringNon invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia. | Procedure or surgery | Children |
Primary outcome
Variation of the instantaneous NIPE index after opioid administration
Time frame: 5 minutes after opioid administration
5 secondary outcomes
the area under the ROC curve of NIPE value
Time frame: Baseline and 5 minutes before the first hemodynamic event.
Variation of the instantaneous NIPE index after skin incision
Time frame: 5 minutes after skin incision
Variation of the instantaneous NIPE index after insertion of airway control device
Time frame: 5 minutes after insertion of airway control device
Variation of the instantaneous NIPE index after removal of airway control device
Time frame: 5 minutes after removal of airway control device
Variation of the instantaneous NIPE index after anesthetic induction
Time frame: 5 minutes after anesthetic induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne LAFFARGUE, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Nociceptive Pain, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the instantaneous NIPE index after opioid administration (time frame: 5 minutes after opioid administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.