Early respiratory therapy and rehabilitation interventions in the role of the prognosis of patients with acute traumatic spinal cord injury

Completed

Conditions: Acute spinal cord injury
Injury, Occupational Diseases, Poisoning
Injury of spinal cord, level unspecified

Registration Number: ISRCTN16066516

Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

1. Acute Spinal Cord Injury (SCI) patients aged 20-70 years old
2. Patients will be enrolled in this study only if full informed written consent is obtained from the patient or their families and they qualify for the above-mentioned diagnostic criteria. The informed written consent will be approved by the Ethics Committee

Exclusion Criteria

1. Severe multiple trauma with unstable hemodynamic status
2. Previous brain insults, such as stroke, traumatic intracranial hemorrhage, meningitis, or degenerative brain diseases that cause central nerve system abnormality
3. Infection or inflammation status before admission
4. Diffuse atherosclerotic changes on extracranial vessels; hematologic disorders that affect leukocyte, platelet count, or function
5. Taking antiplatelet or anticoagulation drugs
6. Major systemic disease, such as end-stage renal diseases, liver cirrhosis, and congestive heart failure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at baseline, 2 weeks, 1 month, 3 months and 6 months:<br>1. Mechanical ventilation free rate (no mechanical ventilator used) at discharge<br>2. Respiratory function:<br>2.1. Maximal inspiratory pressure (MIP) measured with a pressure manometer<br>2.2. Maximal expiratory pressure (MEP) measured with a pressure manometer<br>2.3. Rapid shallow breathing index (RSBI, respiratory rate/tidal volume) measured using Haloscale<br>3. Muscle power of limbs, measured using Japanese Orthopaedic Association (JOA) cervical spine myelopathy functional assessment score

Secondary Outcome Measures

Name	Time	Method
Measured at baseline, 2 weeks, 1 month, 3 months and 6 months:<br>1. Endothelial oxidative stress, measured using ELISA<br>2. DNA damage, measured using RT-PCR<br>3. Inflammation, measured using ELISA<br>4. Leukocyte apoptosis, measured using a flow cytometic assay<br>5. Circulating endothelial progenitor cells (EPCs), measured using a flow cytometric method<br>6. Baroreflex sensitivity, measured using Valsalva maneuver and sequence method<br>7. Cerebral autoregulation, measured using Arterial Spin Labeling (ASL) MRI