Acute carbon monoxide poisoning (ACOP) is a significant cause of morbidity and mortality in many countries, the rate of the largest number of poisoning accidental poisoning of life and occupational poisoning [
ACOP is rather common in winter of China. CO diffuses readily within the alveoli and has far greater affinity than oxygen for essential biological compounds such as hemoglobin and cellular oxidative enzymes. Thus, CO poisoning causes cellular hypoxia. However, the mechanisms of its complications remain unclear [
Although hyperbaric oxygen therapy (HBO) produces a larger reduction in carboxyhemoglobin half-life, its benefit is that risk ratio is still debated [
Twelve Hand Jing Points are of the Chinese traditional medical first aid measures. They have been believed to treat all kinds of emergency for more than 3000 years. Previous studies have shown that THJP may be effective in the first aid treatment of acute carbon monoxide poisoning but have not provided conclusive evidence of THJP bloodletting for acute carbon monoxide poisoning [
This is a multicenter randomized controlled trial, enrolling both men and women with acute carbon monoxide poisoning in China. This study will be conducted at Neurosurgery and Neurology Hospital, Affiliated Hospital, Logistics University of the Chinese People’s Armed Police Force; Wuqing Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, and Tianjin Binhai New Area Dagang Hospital. The patient or the patient’s family should write the informed consent for the study. The compliant patients according to visit order, by the method of central random [
Trail flow chart.
This trial is financed by the National Natural Science Foundation of China (number 81303023). The research protocol has been approved by the Clinical Trial Ethics Committee of Affiliated Hospital of Logistics University of Chinese People’s Armed Police Forces (trial registration number:
Our study will include patients with acute carbon monoxide poisoning. To ensure the precision of results of this trial, patients who meet the following eligible criteria will be included in this study.
Meeting the diagnostic criteria of GBZ23-2002 in acute carbon monoxide poisoning. The course of disease is within 6 hours. After the poisoning patients with disturbance of consciousness.
Patients with delayed encephalopathy after acute carbon monoxide poisoning, cerebral hernia. Liver and kidney function in previous severe abnormality. Pregnant women, diabetes, and mental patients. The blood coagulation dysfunction. Doctors belief that there are some cases not suitable for inclusion. Being not followed up.
The standard of care group will receive general first aid treatment including hyperbaric oxygen therapy (HBO) about 45–60 minutes, citicoline 1 g intravenously once daily, and naloxone 0.4 mg intravenously every 12 hours.
The bloodletting group will receive general first aid treatment, the same as control group. Meanwhile, the bloodletting group will be treated with THJP on admission immediately before hyperbaric oxygen therapy. The order of puncture and bloodletting should be set. In this study, we decide to puncture and bloodlet the left hand first and then the right hand in the order of Shaoshang (LU11), Shangyang (LI1), Zhongchong (PC9), Guan Chong (TE1), Shaochong (HT9), and Shaoze (S11). And the amount of bloodletting at each point is one drop. At the same time, we choose a unified model needle. The location of acupoints is as follows [
In this study, there are two primary outcomes and four secondary outcomes. These are presented in Table
Trial processes chart.
Times | Baseline | Treatment | |||
---|---|---|---|---|---|
−1 | 0 | 0.5 h | 1 h | 4 h | |
Patients | |||||
Medical history | |||||
Physical examination | |||||
Laboratory examination | |||||
Informed consent | |||||
Randomization | |||||
Intervention | |||||
Standard of care group | General first aid treatment | ||||
Bloodletting group | General first aid treatment + THJP | ||||
|
|||||
primary outcomes | |||||
GCS | |||||
COHb | |||||
Secondary outcomes | |||||
T | |||||
P | |||||
R | |||||
BP | |||||
Trial evaluation | |||||
Safety of hand pricking blood therapy | |||||
Adverse event | |||||
Reasons of drop-outs or withdrawals | |||||
Patient’s compliance |
Patients’ states of consciousness (in Glasgow consciousness disorder table of GCS score) are observed at the following time points (before treatment, immediately after treatment, and 30 minutes, 1 hour, and 4 hours after treatment) in two groups. And patients’ carboxyhemoglobin (COHb) concentration of venous blood samples is detected at the following time points (before treatment and 1 hour and 4 hours after treatment) in two groups.
Patients’ basic vital signs including temperature (
Sample size will be based on the primary outcome. According to our pilot trial and review of the literature [
Statistical analysis of all data will be done by Department of Public Health Statistics, which is blinded to this trial, using SPSS 19.0 software packages to analyze the data. All data are provided as mean ± standard deviation. The level of significance was set a
According to TCM theory, the body is regarded as a whole. It is composed of internal and external organs. These organs connect with each other by special ways called meridians [
Twenty participants have been recruited.
Ying Yue and Xingfang Pan are joint first authors.
The authors declare that they have no conflict of interests.
Ying Yue, Xingfang Pan, and Yi Guo conceived the design of the trial and Yi Guo revised it. Ying Yue and Huaien Bu participated in the design of the statistical analysis. Sai Zhang, Dexin Han, Guirong Wang, Qunliang Hu, Jingqing Kang, and Shasha Ding helped in the recruitment of patients. Jun Jin, Wei Wang, Yi Yang, and Dongqiang Wang helped in drafting the paper and quality control. All authors contributed to the final draft of the paper and decided to submit it for publication. All authors read and approved the final paper.
This trial is financed by the National Natural Science Foundation of China (no. 81303023).