An Observational Study to Estimate the Prevalence of Resting Bradycardia, Resting Hypotension and Orthostatic Hypotension in Chronic Traumatic Spinal Cord Injury Patients in Sawai Man Singh Medical College and Attached Hospitals, Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 1. Heart rate in supine and sitting position
研究概览
简要总结
This is an observational study to find out the prevalence of resting bradycardia, resting hypotension and orthostatic hypotension in chronic spinal cord injury that will be conducted in the Department of Physical Medicine and Rehabilitation, SMS Medical College, Jaipur in India. Spinal cord injury (SCI) is one of the most catastrophic traumatic events. Disruption of autonomic pathways makes a highly unstable cardiovascular system which manifests as impaired heart rate and BP regulation with sudden fluctuations which causes significant distress and problems in rehabilitation of spinal cord injury patients. Purpose of this study is to find out the prevalence of resting bradycardia, resting hypotension and orthostatic hypotension in chronic traumatic spinal cord injury patients, assess the association of heart rate with resting hypotension and orthostatic hypotension in these cases and to check whether resting bradycardia, resting hypotension, level, completeness and duration of injury can be used as predictors to orthostatic hypotension for the improvement of the health related quality of life and decrease morbidity and mortality after SCI.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willingly giving an informed written consent to participate in study Patients with traumatic Spinal Cord Injury of duration more than 3 months admitted under department of PMR, SMSMC, Jaipur Patients with SCI of ASIA grades A, B, C or D.
排除标准
- •Patients who are unable to cooperate with the study Previously known cardiac comorbidity or disease prior to the spinal cord injury or taking medications having effects on CVS Head injury or prior neurological disorders like Parkinson’s disease , diabetic autonomic neuropathy or any peripheral neuropathy Present history of neurogenic shock or hypovolemic shock Prior history of psychiatric disorders or drug abuse Completely bedridden patients who are unable or not allowed to sit due to medical illness Severe anemia or pyrexia Patients participating in any other study currently.
结局指标
主要结局
1. Heart rate in supine and sitting position
时间窗: Heart rate, systolic blood pressure and diastolic blood pressure in sitting position should be checked within 3 minutes of sitting in sit up test or at the development of symptoms of hypotension after sitting whichever is earlier
2. Systolic blood pressure in supine and sitting position
时间窗: Heart rate, systolic blood pressure and diastolic blood pressure in sitting position should be checked within 3 minutes of sitting in sit up test or at the development of symptoms of hypotension after sitting whichever is earlier
3. Diastolic blood pressure in supine and sitting position
时间窗: Heart rate, systolic blood pressure and diastolic blood pressure in sitting position should be checked within 3 minutes of sitting in sit up test or at the development of symptoms of hypotension after sitting whichever is earlier
次要结局
- 1.Duration of injury(2.Age)
研究者
Dr Anagha V Nair
SMS Medical College Jaipur