- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02769598
Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance (ANI-DOL)
Pain Management in Pediatric Intensive Care by Studying the Autonomic Balance: Interest of Pain Hetero-assessment by Coupling ANI-HRV-scales : ANI-DOL Study
Fighting against the pain caused by the disease or by the diagnostic and therapeutic procedures for children is a daily and essential concern of health care in the pediatric sector. The quantification of pain is needed to effectively adjust analgesic therapy while limiting the side effects of treatment. Nowadays many scales are validated for children, but they are based on one-off measures and hetero assessments are often subjective and dependent on many factors including the presence of staff to children's sides.
Recent developments in the analysis of the cardiac signal in real time under the influence of autonomic control, have led to the development of a new painful stress quantification index. A monitor has recently been developed and provides an index of nociception and analgesia (ANI index). The validation of this nociception index has not been validated for pediatric care in a sector where particular attention is given to control pain.
The main purpose of this study is to show the consistency of the index compared to a validated pain scale and used routinely in non-sedated children hospitalized in pediatric intensive care units. The caregiver will have the opportunity to fine tune the effective treatment.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Fighting against the pain caused by the disease or by the diagnostic and therapeutic procedures for children is a daily and essential concern of health care in the pediatric sector. The quantification of pain is needed to effectively adjust analgesic therapy while limiting the side effects of treatment. Nowadays many scales are validated for children, but they are based on one-off measures and hetero assessments are often subjective and dependent on many factors including the presence of staff to children's sides.
Recent developments in the analysis of the cardiac signal in real time under the influence of autonomic control, have led to the development of a new painful stress quantification index. A monitor has recently been developed and provides an index of nociception and analgesia (ANI index). It is based on the study of the variability of the heart rate control changes in sympathetic and parasympathetic systems in response to stimuli. Clinical correlations have been completed for most of adult patients during or after general anesthesia. The validation of this nociception index has not been validated for pediatric care in a sector where particular attention is given to control pain.
The main purpose of this study is to show the consistency of the index compared to a validated pain scale and used routinely in non-sedated children hospitalized in pediatric intensive care units. This study is based on a real-time analysis of the perception of pain in children. It is a critical validation step that could dramatically change the treatment of pediatric patients in intensive care and pediatric intensive care units by facilitating real-time patient management. The caregiver will have the opportunity to fine tune the effective treatment. The validation of this stool will allow the pain measure for children highly sedated or presenting a neuromotor handicap.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Saint Etienne, Frankrig, 42055
- CHU Saint-Etienne
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Children hospitalized in pediatric intensive-care unit of the University Hospital of Saint-Etienne, painful and receiving analgesic treatment of level 2 or 3.
Exclusion Criteria:
- Children in therapy or neurological coma,
- Children enjoying a treatment known to change the ortho or parasympathetic system.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
ANI Index for Hospitalized children
Each child will be registered upon arrival in the service and for a period of 24 hours. Registration will finish at the end of 24 hours or when the patient is discharged from the service. A FLACC scale (Face, Legs, Activity, Cry, Consolability scale) will be performed at the patient's input and then once every 4 hours corresponding to the patient's baseline. A FLACC scale will then be performed at each painful episode of the patient and 30 minutes after the end of production of analgesic treatment corresponding to the post-treatment painful condition of the patient. A measurement of blood pressure will be performed at each pain rating by the patient assisted by the nurse. |
Each file consists of a simultaneous recording of an ECG signal, according to usual practice, coupled with a record of ANI Index (Analgesia Nociception Index) by MetroDoloris®.
The ECG signals and the ANI index are recorded simultaneously on a computer.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ANI Index
Tidsramme: 24 hours
|
ANI Index will be measured during 24 hours and coated from 0 to 100 to have an idea of the patient's pain.
It will also be compared to the FLACC Score (Face-Legs-Activity-Cry-Consolability Score) that is routinely measured and coated from 0 to 10.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
HFnu Index
Tidsramme: 24 hours
|
High Standard Frequency Index (HFnu) of Short Term RR variability in heart rate (HRV) in the frequency domain will be measured at 24 hours.
|
24 hours
|
|
Ptot
Tidsramme: 24 hours
|
Ptot is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
VLF
Tidsramme: 24 hours
|
VLF (Very Low Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
LF
Tidsramme: 24 hours
|
LF (Low frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
HF
Tidsramme: 24 hours
|
HF (High Frequencies) is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
LF/HF Ratio
Tidsramme: 24 hours
|
LF (Low Frequencies) / HF (High Frequencies) Ratio is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
SDNN
Tidsramme: 24 hours
|
SDNN (Standard Deviation of all NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
SDANN
Tidsramme: 24 hours
|
SDANN (Standard Deviation of the Averages of NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
|
pNN50
Tidsramme: 24 hours
|
pNN50 (NN50 count divided by the total number of all NN intervals) is a cardiac frequency variability index and it will be measured at 24 hours.
|
24 hours
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1500012
- 1956629 (Anden identifikator: CNIL)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ANI Index for Hospitalized children
-
University Hospital, BordeauxAfsluttetFlydende reaktionsevne | VolumenudvidelseFrankrig
-
Investigation Group Anesthesia, Resuscitation,...RekrutteringSkrøbelighed i voksenkirurgiSpanien
-
İstanbul Yeni Yüzyıl ÜniversitesiIkke rekrutterer endnuSmerte | Intensiv afdelings syndrom | Stressrelateret lidelse
-
Wonkwang University HospitalAfsluttetAnalgesi | Smerter, Akut | Nociceptiv smerteKorea, Republikken
-
University of British ColumbiaAfsluttetAngst | Kejsersnit | OpioidforbrugCanada
-
Seoul National University Bundang HospitalAfsluttetKejsersnitKorea, Republikken
-
Marmara UniversityRekrutteringLumbal spinal stenose | Lumbal Disc Degeneration | Lumbal degenerativ spondylolistese | Lumbal Diskusprolaps Med RadikulopatiTyrkiet (Türkiye)
-
Trakya UniversityAfsluttetSmerter, postoperativ | Analgesi | Hypofyse neoplasmer | Supratentorial hjernetumor | Infratentoriale neoplasmer | Intraoperativ overvågning | SmerteovervågningKalkun
-
Seoul National University HospitalRekruttering
-
Assistance Publique - Hôpitaux de ParisAfsluttet