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手术室环境温度对新生儿发病率影响的随机试验

A Randomized Trial of the Effects of Ambient Operating Room Temperature on Neonatal Morbidity.

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.

Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.

出版信息

Am J Perinatol. 2024 May;41(S 01):e1553-e1559. doi: 10.1055/a-2053-7242. Epub 2023 Mar 14.

DOI:10.1055/a-2053-7242
PMID:36918157
Abstract

OBJECTIVE

Newborn hypothermia has been implicated in neonatal morbidity without randomized evidence that it compromises the infant. Our objective was to determine if a difference in operating room temperature at cesarean birth impacts neonatal morbidity.

STUDY DESIGN

Women undergoing cesarean delivery of a liveborn infant without major malformations were included. The institutional preexisting operating room temperature of 20°C (67°F) was compared with an experimental group of 24°C (75°F) by cluster randomization assigned on a weekly basis. Newborn hypothermia was defined as axillary temperature on arrival to the nursery of less than 36.5°C (<97.7°F). The primary outcome was a composite of neonatal morbidity including respiratory support, sepsis, hypoglycemia, and neonatal death.

RESULTS

Between November 2016 and May 2018, 5,221 women had cesarean deliveries at Parkland Hospital with 2,817 randomized to the standard care group and 2,404 to the experimental group. The rate of neonatal composite morbidity did not differ between the groups: standard care 398 (14%) versus experimental 378 (16%),  = 0.11. This was despite a significant decrease in the rate of neonatal hypothermia: standard care 1,195 (43%) versus experimental 414 (18%),  < 0.001. There was no difference in the composite outcome for preterm infants (<37 wk) between the groups: standard care 194 (49%) versus experimental 185 (54%),  = 0.25.

CONCLUSION

An 8°F increase in operating room temperature was significantly associated with a reduced rate of neonatal hypothermia, although this decrease was not associated with a significant improvement in neonatal morbidity. However, the increase in operating room temperature was met with resistance from obstetricians and operating room personnel. This trial is registered (registration no.: NCT03008577).

摘要

目的

新生儿低体温与新生儿发病率有关,但尚无随机证据表明其会损害婴儿。我们的目的是确定剖宫产术中手术室温度的差异是否会影响新生儿发病率。

研究设计

本研究纳入了无重大畸形的活产儿剖宫产的产妇。将 20°C(67°F)的机构手术室原有温度与每周按集群随机分配的 24°C(75°F)实验组进行比较。新生儿低体温定义为到达婴儿室时的腋温低于 36.5°C(97.7°F)。主要结局是包括呼吸支持、败血症、低血糖和新生儿死亡在内的新生儿发病率的复合结局。

结果

2016 年 11 月至 2018 年 5 月,Parkland 医院共有 5221 名妇女行剖宫产术,其中 2817 名随机分配至标准护理组,2404 名分配至实验组。两组新生儿复合发病率无差异:标准护理组 398 例(14%),实验组 378 例(16%),=0.11。尽管新生儿低体温的发生率显著降低:标准护理组 1195 例(43%),实验组 414 例(18%),<0.001。两组早产儿(<37 周)复合结局无差异:标准护理组 194 例(49%),实验组 185 例(54%),=0.25。

结论

手术室温度升高 8°F 与新生儿低体温发生率降低显著相关,尽管这种降低与新生儿发病率的显著改善无关。然而,增加手术室温度遭到了产科医生和手术室人员的抵制。本试验已注册(注册号:NCT03008577)。

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