Heart Rate Variability in Children With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— HRV-TBI  

Official title:

Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701620
• Other study ID #: HSJ 2018-1575
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: February 10, 2021

Study information

• Verified date: October 2021
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 10, 2021
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Child Development
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• HRV monitoring
HRV monitoring derived from electrocardiogram

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of the time with reliable HRVmonitoring in children with TBI	Feasibility of having a reliable capture and analysis of HRV 7 days post TBI	1 year
Secondary	Rate of adverse events preceded by a decreased HRV	Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest	1 year
Secondary	HRV and neurological outcome	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)	1.5 year