Pre-hospital and in-hospital first aid programs and specifications for spine and spinal cord injury in Beijing, China: study protocol for a prospective, multicenter, nonrandomized controlled trial

Abstract

Background: The optimal time to rescue spinal cord function after spinal cord injury is within 24 hours, especially within 3 to 8 hours, after the injury. Timely and proper pre-hospital first aid, hospital admission, patient assessment, and surgery are essential for the rescue of spinal cord function. A sound and rapid treatment system is the basis for improving the level of injury treatment and recovery of spinal cord function. China currently lacks a systematic and standardized treatment system. Methods/Design: We herein propose our study protocol for a prospective, multicenter, nonrandomized controlled trial. We will recruit 200 patients with acute spinal cord injury undergoing pre-hospital treatment at Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center and receiving in-hospital treatment at Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. This study will comprise two parts: (1) establishment of a database of patients with spinal cord injury in the Beijing area; and (2) formulation of the pre-hospital and in-hospital process and establishment of a standardized treatment protocol for acute spinal cord injury. The primary outcome will be the American Spinal Injury Association impairment scale score for spinal nerve function. The secondary outcomes will be spinal X-ray, three-dimensional computed tomography, and magnetic resonance imaging findings and the incidence of complications due to improper pre-hospital and in-hospital treatment of acute spinal cord injury. Discussion: The aims of this study are as follows: (1) We will establish a spine and spinal cord injury treatment database in the Beijing area. (2) We will assess the complete pre-hospital and in-hospital evaluation of spine and spinal cord injury, develop and optimize first aid procedures, and create a pre-hospital and in-hospital standardized training program for the treatment of spine and spinal cord injury. (3) We will build a pre-hospital and in-hospital first aid “green channel” for acute spine and spinal cord injury after completion of the study. (4) We will develop first aid guidelines and establish an evaluation and treatment system for early surgery to save spinal cord function and reduce the degree of disability to the greatest extent as possible. (5) We anticipate that our results will be used in expert consensuses on acute spinal cord injury and that “green channel” patterns will be promoted in hospitals in Beijing and other cities of China to improve the level of first aid treatment of acute spine and spinal cord injury in Chinese cities and reduce the occurrence of secondary injury and severe dysfunction due to improper treatment. This trial will begin in May 2017. Patient recruitment will be finished in August 2019. Analysis of all data and results will be completed in December 2020. Trial registration: ClinicalTrials.gov identifier: NCT03103516. Ethics: All protocols will be in accordance with Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki (2013), formulated by the World Medical Association. The study protocol has been approved by the Medical Ethics Committee of Peking University People's Hospital, China (approval number: 2016PHB136-01). Informed consent: Written informed consent will be provided by legal representative of participants.