Birch Daniel W, Dang Jerry T, Switzer Noah J, Manouchehri Namdar, Shi Xinzhe, Hadi Ghassan, Karmali Shahzeer
Center for the Advancement of Minimally Invasive Surgery, Department of Surgery, University of Alberta, Royal Alexandra Hospital, Rm. 418 CSC, 10240 Kingsway Ave, Edmonton, AB, Canada, T5H 3V9.
Cochrane Database Syst Rev. 2016 Oct 19;10(10):CD007821. doi: 10.1002/14651858.CD007821.pub3.
Intraoperative hypothermia during both open and laparoscopic abdominal surgery may be associated with adverse events. For laparoscopic abdominal surgery, the use of heated insufflation systems for establishing pneumoperitoneum has been described to prevent hypothermia. Humidification of the insufflated gas is also possible. Past studies on heated insufflation have shown inconclusive results with regards to maintenance of core temperature and reduction of postoperative pain and recovery times.
To determine the effect of heated gas insufflation compared to cold gas insufflation on maintaining intraoperative normothermia as well as patient outcomes following laparoscopic abdominal surgery.
We searched Cochrane Colorectal Cancer Specialised Register (September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 8), Ovid MEDLINE (1950 to September 2016), Ovid Embase (1974 to September 2016), International Pharmaceutical Abstracts (IPA) (September 2016), Web of Science (1985 to September 2016), Scopus, www.clinicaltrials.gov and the National Research Register (1956 to September 2016). We also searched grey literature and cross references. Searches were limited to human studies without language restriction.
Only randomised controlled trials comparing heated (with or without humidification) with cold gas insufflation in adult and paediatric populations undergoing laparoscopic abdominal procedures were included. We assessed study quality in regards to relevance, design, sequence generation, allocation concealment, blinding, possibility of incomplete data and selective reporting. Two review authors independently selected studies for the review, with any disagreement resolved in consensus with a third co-author.
Two review authors independently performed screening of eligible studies, data extraction and methodological quality assessment of the trials. We classified a study as low-risk of bias if all of the first six main criteria indicated in the 'Risk of Bias Assessment' table were assessed as low risk. We used data sheets to collect data from eligible studies. We presented results using mean differences for continuous outcomes and relative risks for dichotomous outcomes, with 95% confidence intervals. We used Review Manager (RevMan) 5.3 software to calculate the estimated effects. We took publication bias into consideration and compiled funnel plots.
We included 22 studies in this updated analysis, including six new trials with 584 additional participants, resulting in a total of 1428 participants. The risk of bias was low in 11 studies, high in one study and unclear in the remaining studies, due primarily to failure to report methodology for randomisation, and allocation concealment or blinding, or both. Fourteen studies examined intraoperative core temperatures among heated and humidified insufflation cohorts and core temperatures were higher compared to cold gas insufflation (MD 0.31 °C, 95% CI, 0.09 to 0.53, I = 88%, P = 0.005) (low-quality evidence). If the analysis was limited to the eight studies at low risk of bias, this result became non-significant but remained heterogeneous (MD 0.18 °C, 95% CI, -0.04 to 0.39, I= 81%, P = 0.10) (moderate-quality evidence).In comparison to the cold CO group, the meta-analysis of the heated, non-humidified group also showed no statistically significant difference between groups. Core temperature was statistically, significantly higher in the heated, humidified CO with external warming groups (MD 0.29 °C, 95% CI, 0.05 to 0.52, I = 84%, P = 0.02) (moderate-quality evidence). Despite the small difference in temperature of 0.31 °C with heated CO, this is unlikely to be of clinical significance.For postoperative pain scores, there were no statistically significant differences between heated and cold CO, either overall, or for any of the subgroups assessed. Interestingly, morphine-equivalent use was homogeneous and higher in heated, non-humidified insufflation compared to cold insufflation for postoperative day one (MD 11.93 mg, 95% CI 0.92 to 22.94, I = 0%, P = 0.03) (low-quality evidence) and day two (MD 9.79 mg, 95% CI 1.58 to 18.00, I = 0%, P = 0.02) (low-quality evidence). However, morphine use was not significantly different six hours postoperatively or in any humidified insufflation groups.There was no apparent effect on length of hospitalisation, lens fogging or length of operation with heated compared to cold gas insufflation, with or without humidification. Recovery room time was shorter in the heated cohort (MD -26.79 minutes, 95% CI -51.34 to -2.25, I = 95%, P = 0.03) (low-quality evidence). When the one and only unclear-risk study was removed from the analysis, the difference in recovery-room time became non-significant and the studies were statistically homogeneous (MD -1.22 minutes, 95% CI, -6.62 to 4.17, I = 12%, P = 0.66) (moderate-quality evidence).There were also no differences in the frequency of major adverse events that occurred in the cold or heated cohorts.These results should be interpreted with caution due to some limitations. Heterogeneity of core temperature remained significant despite subgroup analysis, likely due to variations in the study design of the individual trials, as the trials had variations in insufflation gas temperatures (35 ºC to 37 ºC), humidity ranges (88% to 100%), gas volumes and location of the temperature probes. Additionally, some of the trials lacked specific study design information making evaluation difficult.
AUTHORS' CONCLUSIONS: While heated, humidified gas leads to mildly smaller decreases in core body temperatures, clinically this does not account for improved patient outcomes, therefore, there is no clear evidence for the use of heated gas insufflation, with or without humidification, compared to cold gas insufflation in laparoscopic abdominal surgery.
开腹手术和腹腔镜腹部手术期间的术中低温可能与不良事件相关。对于腹腔镜腹部手术,已有使用加热充气系统建立气腹以预防低温的描述。对充气气体进行加湿也是可行的。过去关于加热充气的研究在维持核心体温、减轻术后疼痛及缩短恢复时间方面的结果尚无定论。
确定与冷气体充气相比,加热气体充气对维持腹腔镜腹部手术后术中正常体温及患者预后的影响。
我们检索了Cochrane结直肠癌专科注册库(2016年9月)、Cochrane对照试验中心注册库(CENTRAL;Cochrane图书馆2016年第8期)、Ovid MEDLINE(1950年至2016年9月)、Ovid Embase(1974年至2016年9月)、国际药学文摘(IPA)(2016年9月)、科学引文索引(1985年至2016年9月)、Scopus、www.clinicaltrials.gov以及国家研究注册库(1956年至2016年9月)。我们还检索了灰色文献和交叉参考文献。检索限于无语言限制的人体研究。
仅纳入比较加热(有或无加湿)与冷气体充气,用于接受腹腔镜腹部手术的成人和儿童人群的随机对照试验。我们从相关性、设计、序列产生、分配隐藏、盲法、数据不完整可能性及选择性报告方面评估研究质量。两位综述作者独立选择纳入综述的研究,如有分歧则与第三位共同作者协商解决。
两位综述作者独立进行合格研究的筛选、数据提取及试验的方法学质量评估。如果“偏倚风险评估”表中列出的前六项主要标准均被评估为低风险,我们将一项研究归类为低偏倚风险。我们使用数据表从合格研究中收集数据。我们使用连续结局的均值差和二分结局的相对风险呈现结果,并给出95%置信区间。我们使用Review Manager(RevMan)5.3软件计算估计效应。我们考虑了发表偏倚并编制了漏斗图。
我们在本次更新分析中纳入了22项研究,包括6项新试验及另外584名参与者,共计1428名参与者。11项研究的偏倚风险较低,1项研究的偏倚风险较高,其余研究的偏倚风险不明确,主要原因是未报告随机化方法、分配隐藏或盲法,或两者皆未报告。14项研究检查了加热和加湿充气组的术中核心体温,与冷气体充气相比,核心体温更高(均值差0.31℃,95%置信区间0.09至0.53,I² = 88%,P = 0.005)(低质量证据)。如果分析仅限于偏倚风险较低的8项研究,该结果无统计学意义,但仍存在异质性(均值差0.18℃,95%置信区间 -0.04至0.39,I² = 81%,P = 0.10)(中等质量证据)。与冷二氧化碳组相比,加热、未加湿组的荟萃分析也显示两组之间无统计学显著差异。加热、加湿二氧化碳与外部加温组的核心体温在统计学上显著更高(均值差0.29℃,95%置信区间0.05至0.52,I² = 84%,P = 0.02)(中等质量证据)。尽管加热二氧化碳时体温仅有0.31℃的微小差异,但这可能不具有临床意义。对于术后疼痛评分,加热和冷二氧化碳组之间总体或任何评估的亚组均无统计学显著差异。有趣的是,术后第一天,加热、未加湿充气组的吗啡等效用量具有同质性且高于冷充气组(均值差11.93mg,95%置信区间0.92至22.94,I² = 0%,P = 0.03)(低质量证据),术后第二天也是如此(均值差9.79mg,95%置信区间1.58至18.00,I² = 0%,P = 0.02)(低质量证据)。然而,术后6小时或任何加湿充气组的吗啡用量无显著差异。与冷气体充气相比,无论有无加湿,加热气体充气对住院时间、镜头起雾或手术时长均无明显影响。加热组的恢复室时间更短(均值差 -26.79分钟,95%置信区间 -51.34至 -2.25,I² = 95%,P = 0.03)(低质量证据)。当分析中剔除唯一一项偏倚风险不明确的研究时,恢复室时间的差异变得无统计学意义,且研究在统计学上具有同质性(均值差 -1.22分钟,95%置信区间 -6.62至4.17,I² = 12%,P = 0.66)(中等质量证据)。冷组或加热组发生的主要不良事件频率也无差异。由于存在一些局限性,这些结果应谨慎解释。尽管进行了亚组分析,但核心体温的异质性仍然显著,这可能是由于各个试验的研究设计存在差异,因为试验中的充气气体温度(35℃至37℃)、湿度范围(88%至100%)、气体体积及温度探头位置各不相同。此外,一些试验缺乏具体的研究设计信息,难以进行评估。
虽然加热、加湿气体导致核心体温下降幅度略小,但在临床上这并未改善患者预后,因此,与冷气体充气相比,尚无明确证据支持在腹腔镜腹部手术中使用加热气体充气,无论是否加湿。