Objective To observe the effect and safety of the endovascular hypothermia through hypothermic intravenous infusion device in the treatment of patients with severe craniocerebral injury compared with conventional surface cooling. Methods A total of 66 cases of patients with severe cranio-cerebral injury were randomly divided into the observation group and the control group with 33 cases in each group according to envelop randomization. The control group received surface cooling, and the observation group was given surface cooling plus endovascular hypothermia through hypothermic intravenous infusion device. The target temperature was 35 ℃ maintained for 3-5 days, and natural rewarming was applied at the speed of 0.1-0.5 ℃/h to 36.0-37.3 ℃. The time to reach target temperature, the constant stability, the incidence rate and severity of complication such as shiver, arrhythmia, skin injury and agitation were recorded and compared between two groups, as well as the heart rate, breathing rate, pulse rate, blood pressure and Glasgow Coma Scale (GCS) scores after 72 h of treatment. Glasgow Outcome Scale scores 30 days after treatment and nursing workload were also calculated and compared. Results The cooling speed, time to reach target temperature and the ability to maintain at 35 ℃ were (1.3±0.2) ℃/h, (2.3±0.2) h and (6.5±1.8)% in the observation group, respectively, compared with (0.5±0.1) ℃/h, (3.6±0.6) h and (11.3±2.2)% in the control group, which had significant differences (t=1.862, 2.112, 2.408, P < 0.05). The occurrence rates of shiver, arrhythmia, skin damage and dysphoria and restlessness in the observation group were 33.33% (11/33), 9.09% (3/33), 6.06% (2/33) and 27.27% (9/33), respectively, which were much lower than those in the control group 84.85% (28/33), 15.15% (5/33), 33.33% (11/33), 54.55% (18/33), χ2=1.764-2.733, P < 0.05. The heart rate, breathing rate, pulse rate, systolic blood pressure and GCS score after 72 h of treatment were (68.31±3.73) times/min, (16.60±1.52) times/min, (136.35±3.71) mmHg (1 mmHg=0.133 kPa) , (34.61±1.05) ℃, (9.91±4.05) points in the observation group, while (58.31±3.62) times/min, (19.81±1.83) times/min, (150.66±2.70) mmHg, (35.65±1.36) ℃, (7.63±3.17) points in the control group, and there were significant differences between two groups (t=2.275-3.035, P < 0.05) .Besides, the ice-changing ice and turning-over time in the observation group were both remarkably reduced compared with control group, (14.03±3.11) min/h vs (38.12±2.70) min/h (t=3.356, P < 0.05), (15.08±3.07) min/h vs (26.16±2.54) min/h (t=3.021, P < 0.05). Patients with good recovery, mild disability, severe disability, death in the observation group were 16, 13, 3 and 1 case, while 6, 11, 9, 7 cases in the control group (χ2=2.351, P < 0.05). Conclusions The endovascular hypothermia through hypothermic intravenous infusion device can rapidly reduce and effectively maintain target temperature, reduce the incidence rate of complication, improve the vital signs and decrease the nursing workload in order to improve neurological outcome in the treatment of patients with severe craniocerebral injury. Key words: Craniocerebral trauma; Hypothermic intravenous infusion device; Endovascular hypothermia
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