Heart Rate Variability in Children With Traumatic Brain Injury

Completed

• Conditions: Traumatic Brain Injury; Child Development

• Registration Number: NCT03701620
• Lead Sponsor: St. Justine's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Primary Completion: 2019-07-05
• Study Completion: 2021-02-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of the time with reliable HRVmonitoring in children with TBI	1 year	Feasibility of having a reliable capture and analysis of HRV 7 days post TBI

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events preceded by a decreased HRV	1 year	Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest
HRV and neurological outcome	1.5 year	The primary outcome of neurological and functional outcome will be assessed by the Pediatric Glasgow Outcome Scale Extended (P-GOSE) 6 months post TBI. P-GOSE is an 8-point ordinal scale (1= best outcome) The score will be classified as favourable (P-GOSE 1 or 2, or decreased of P-GOSE of 1 point post PICU (∆ P-GOSE ≤1) or unfavourable (P-GOSE ≥3 or ∆ P-GOSE ≥2)

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada