Does Heart Rate Variablity (HRV) Predict Hypotension in Patients Undergoing Cervical Myelopathy Surgery ?
1 other identifier
observational
65
1 country
1
Brief Summary
Cervical myelopathy is commonly associated with degenerative spinal disease. Dysfunction of the autonomic nervous system is also evident in many cases of cervical myelopathy. Autonomic dysfunction may result in haemodynamic instability and hypotension under anaesthesia. It is important to maintain adequate mean arterial pressure in order to perfuse the spinal cord and prevent cord ischemia. Heart rate variability, the physiological variations of the differences between heart beats, has been used to diagnose autonomic dysfunction. In patients with cervical myelopathy it may enable the anaesthetist to predict hypotension thereby allowing for early treatment and prevention of spinal cord ischemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedResults Posted
Study results publicly available
December 16, 2020
CompletedDecember 22, 2022
December 1, 2022
4.7 years
February 2, 2015
May 11, 2020
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Heart Rate Variability (HRV)
Difference between total power (ms2) of patients in the hypotension group compared to stable group
1 day
HRV Indices
Differences in HRV indices between hypotension group and no hypotension group
1 day
Mean Arterial Pressure
Preoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group
one day
HRV Indices Analysis
Low frequency (LF)/High frequency Ratio
One day
Eligibility Criteria
Patients with cervical myelopathy presenting for cervical spine surgery at Toronto Western Hospital.
You may qualify if:
- Adults patients, aged 18 - 70 years with the history of cervical myelopathy, presenting for anterior or posterior cervical decompression and fusion.
You may not qualify if:
- Patients with arrhythmias or absence of sinus rhythm
- Diabetic patients
- Degenerative neurological disease e.g. Parkinson's disease
- Complete SCI
- Inherited autonomic dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T2S8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emad Al Azazi
- Organization
- Toronto Western Hospital/UHN
Study Officials
- PRINCIPAL INVESTIGATOR
Lashmi Venkatraghavan, MD
Department of Anesthesia, Toronto Western Hospital. University of Toronto
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Neuroanesthesia, Toronto Western Hospital
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 10, 2015
Study Start
February 1, 2015
Primary Completion
October 1, 2019
Study Completion
April 1, 2020
Last Updated
December 22, 2022
Results First Posted
December 16, 2020
Record last verified: 2022-12