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围手术期高氧分数对腹部手术后手术部位感染和肺部并发症的影响:PROXI随机临床试验

Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial.

作者信息

Meyhoff Christian S, Wetterslev Jørn, Jorgensen Lars N, Henneberg Steen W, Høgdall Claus, Lundvall Lene, Svendsen Poul-Erik, Mollerup Hannah, Lunn Troels H, Simonsen Inger, Martinsen Kristian R, Pulawska Therese, Bundgaard Lars, Bugge Lasse, Hansen Egon G, Riber Claus, Gocht-Jensen Peter, Walker Line R, Bendtsen Asger, Johansson Gun, Skovgaard Nina, Heltø Kim, Poukinski Andrei, Korshin André, Walli Aqil, Bulut Mustafa, Carlsson Palle S, Rodt Svein A, Lundbech Liselotte B, Rask Henrik, Buch Niels, Perdawid Sharafaden K, Reza Joan, Jensen Kirsten V, Carlsen Charlotte G, Jensen Frank S, Rasmussen Lars S

机构信息

Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

出版信息

JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.

DOI:10.1001/jama.2009.1452
PMID:19826023
Abstract

CONTEXT

Use of 80% oxygen during surgery has been suggested to reduce the risk of surgical wound infections, but this effect has not been consistently identified. The effect of 80% oxygen on pulmonary complications has not been well defined.

OBJECTIVE

To assess whether use of 80% oxygen reduces the frequency of surgical site infection without increasing the frequency of pulmonary complications in patients undergoing abdominal surgery.

DESIGN, SETTING, AND PATIENTS: The PROXI trial, a patient- and observer-blinded randomized clinical trial conducted in 14 Danish hospitals between October 2006 and October 2008 among 1400 patients undergoing acute or elective laparotomy.

INTERVENTIONS

Patients were randomly assigned to receive either 80% or 30% oxygen during and for 2 hours after surgery.

MAIN OUTCOME MEASURES

Surgical site infection within 14 days, defined according to the Centers for Disease Control and Prevention. Secondary outcomes included atelectasis, pneumonia, respiratory failure, and mortality.

RESULTS

Surgical site infection occurred in 131 of 685 patients (19.1%) assigned to receive 80% oxygen vs 141 of 701 (20.1%) assigned to receive 30% oxygen (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.72-1.22; P = .64). Atelectasis occurred in 54 of 685 patients (7.9%) assigned to receive 80% oxygen vs 50 of 701 (7.1%) assigned to receive 30% oxygen (OR, 1.11; 95% CI, 0.75-1.66; P = .60), pneumonia in 41 (6.0%) vs 44 (6.3%) (OR, 0.95; 95% CI, 0.61-1.48; P = .82), respiratory failure in 38 (5.5%) vs 31 (4.4%) (OR, 1.27; 95% CI, 0.78-2.07; P = .34), and mortality within 30 days in 30 (4.4%) vs 20 (2.9%) (OR, 1.56; 95% CI, 0.88-2.77; P = .13).

CONCLUSION

Administration of 80% oxygen compared with 30% oxygen did not result in a difference in risk of surgical site infection after abdominal surgery.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00364741.

摘要

背景

有人提出在手术期间使用80%的氧气可降低手术伤口感染风险,但这一效果尚未得到一致确认。80%的氧气对肺部并发症的影响也未明确界定。

目的

评估在接受腹部手术的患者中,使用80%的氧气是否能降低手术部位感染的发生率,同时不增加肺部并发症的发生率。

设计、地点和患者:PROXI试验,这是一项患者和观察者双盲的随机临床试验,于2006年10月至2008年10月在14家丹麦医院对1400例接受急性或择期剖腹手术的患者进行。

干预措施

患者被随机分配在手术期间及术后2小时接受80%或30%的氧气。

主要观察指标

根据美国疾病控制与预防中心的定义,术后14天内的手术部位感染。次要结局包括肺不张、肺炎、呼吸衰竭和死亡率。

结果

在分配接受80%氧气的685例患者中,有131例(19.1%)发生手术部位感染;而在分配接受30%氧气的701例患者中,有141例(20.1%)发生手术部位感染(优势比[OR]为0.94;95%置信区间[CI]为0.72 - 1.22;P = 0.64)。在分配接受80%氧气的685例患者中,有54例(7.9%)发生肺不张;而在分配接受30%氧气的701例患者中,有50例(7.1%)发生肺不张(OR为1.11;95%CI为0.75 - 1.66;P = 0.60),肺炎发生率分别为41例(6.0%)和44例(6.3%)(OR为0.95;95%CI为0.61 - 1.48;P = 0.82),呼吸衰竭发生率分别为38例(5.5%)和31例(4.4%)(OR为1.27;95%CI为0.78 - 2.07;P = 0.34),30天内死亡率分别为30例(4.4%)和20例(2.9%)(OR为1.56;95%CI为0.88 - 2.77;P = 0.13)。

结论

与30%的氧气相比,给予80%的氧气并未导致腹部手术后手术部位感染风险出现差异。

试验注册

clinicaltrials.gov标识符:NCT00364741。

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