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临床试验/NCT02586974
NCT02586974已完成不适用

Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response: Head-to-head Randomized Comparison Versus Standard Insufflation During Robot Assisted Radical Prostatectomy

A.O.U. Città della Salute e della Scienza2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Intraoperative Change in Body Core Temperature

研究概览

简要总结

The aim of this study is to assess if the conditioning of the insufflation carbon dioxide (CO2) allows for an additional benefit in terms of prevention of the heat loss, when compared with the usual prevention with a forced warm air blanket alone, in the setting of robot-assisted radical prostatectomy (RARP).

详细描述

Among the possible consequences of cool and dry gas insufflation during laparoscopic procedures are hypothermia and cytokine response, which might cause significant perioperative morbidity. More in detail, body core temperature decrease during laparoscopic surgery has been calculated in humans as 0.3 °C for every 50 L of cold and dry insufflation gas. The reported temperature drop is caused by redistribution of heat and heat loss, both non-specific (due to anaesthesia and environmental patient exposure) and specific (due to peritoneal dry and cool insufflations). The resulting hypothermia can be severe, particularly after prolonged surgery. As for cytokine response, an increase of several pro-inflammatory cytokines has been described following the irritating effect of peritoneal CO2 insufflation.

That said, various devices of conditioning of the insufflating gas have been investigated to reduce the specific heat losses resulting from peritoneal insufflations, as well as to evaluate the inflammatory response. Previous studies conducted on animal models and clinical settings have suggested that warmed and humidified insufflation allows for an improved maintenance of body core temperature, a reduction in the degree of inflammatory response and an improved quality of postoperative course, compared with standard insufflating gas. These findings, however, are still not conclusive as they have not been confirmed by adequate randomized, controlled trials. Furthermore, no device providing warming and humidification has demonstrated a conclusive advantage over standard cold dry gas in terms of prevention of hypothermia during laparoscopy in man.

On the basis of the current available studies favouring warmed and humidified insufflation, the investigators hypothesize that a new device providing warmed and humidified insufflation (Humigard® Fisher and Paykel Healthcare®) might achieve significant benefits over standard insufflation in terms of body core temperature maintenance. The investigators also expect to document a decrease of pro-inflammatory cytokines, as a response to a diminished peritoneal irritation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • all patients undergoing RARP, with or without pelvic lymph node dissection, with a CO2 insufflation scheduled to last more than 60 minutes

排除标准

  • patients over 80 years old, patients American Society of Anesthesiologist (ASA) status 4 or higher, patients not willing to sign the informed consent, conversions to open surgery

结局指标

主要结局

Intraoperative Change in Body Core Temperature

时间窗: Intraoperative at hourly intervals

body core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe

次要结局

  • Cytokine Tumor Necrosis Factor (TNF)-Beta(changes in cytokine levels just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery)
  • Cytokine Interleukin-6 (IL-6)(changes in cytokine levels measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery)
  • Postoperative Pain(changes in postoperative pain measured at patient awakening and then every 30 min in the recovery room, until discharge to the ward. Successively, it was measured at 12, 24, and 48 h)

研究者

发起方
A.O.U. Città della Salute e della Scienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Oderda

PhD fellow

A.O.U. Città della Salute e della Scienza

研究点 (2)

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