Heart Rate Variability in Children With Traumatic Brain Injury

NCT ID: NCT03701620

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-02-10

Brief Summary

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Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

Detailed Description

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This is a single center prospective cohort study of 15 children \<18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (\<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.

Conditions

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Traumatic Brain Injury Child Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HRV monitoring

HRV monitoring derived from electrocardiogram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* \<18 years
* admitted to the PICU at the CHUSJ
* moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room
* written parental consent.

Exclusion Criteria

* children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)
* children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)
* inflicted trauma (different underlying pathophysiology)
* patients or parents who do not speak or read English or French.
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Laurence Ducharme-Crevier

Pediatric intensivist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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HSJ 2018-1575

Identifier Type: -

Identifier Source: org_study_id

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