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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.
Protocol
Data Collection and Management Data Collection The following data will be collected: patient demographics, surgical data including position technique, number of levels, duration, anaesthetic data including agents used, hemodynamic measurements from preinduction to surgical incision, Japanese Orthopaedic Association Score. The incidence of hypotension and the number of interventions required to keep mean arterial blood pressure above 70 mmHg will be recorded.
Significance of the study Identifying patients at risk for hypotension can be useful to prevent hypotension and to prepare to treat hypotension sooner so that the risk of spinal cord ischemia can be minimized.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cervical myelopathy presenting for cervical spine surgery at Toronto Western Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Lashmi Venkatraghavan, MD | Department of Anesthesia, Toronto Western Hospital. University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Myelopathy Undergoing Spine Surgery | This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In total 65 patients were recruited for the study and 16 patients were excluded. 49 patients were included for final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Myelopathy Undergoing Spine Surgery | This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate Variability (HRV) | Difference between total power (ms2) of patients in the hypotension group compared to stable group | All data are presented as Median [Interquartile range] | Posted | Median | Inter-Quartile Range | ms2 | 1 day |
|
|
1 year
No adverse event observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Heart Rate Variability in Patients with Cervical Myelopathy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emad Al Azazi | Toronto Western Hospital/UHN | 416-603-8500 | 6237 | emad.alazazi@uhnresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2014 | May 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| years |
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| Sex: Female, Male | 49 patients were included for final analysis. | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cervical myelopathy | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | HRV Indices | Differences in HRV indices between hypotension group and no hypotension group | All data are presented as Median [Interquartile range]. VLF- very low frequency, LF-low frequency, HF- high frequency. | Posted | Median | Inter-Quartile Range | ms2 | 1 day |
|
|
|
| Primary | Mean Arterial Pressure | Preoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group | All data are presented as Median [Interquartile range] | Posted | Median | Inter-Quartile Range | mmHg | one day |
|
|
|
| Primary | HRV Indices Analysis | Low frequency (LF)/High frequency Ratio | Low Frequency to High Frequency ratio. All data are presented as Median [Interquartile range]. | Posted | Median | Inter-Quartile Range | Ratio | One day |
|
|
|
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
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| HF |
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