Moller J T, Pedersen T, Rasmussen L S, Jensen P F, Pedersen B D, Ravlo O, Rasmussen N H, Espersen K, Johannessen N W, Cooper J B
Department of Anesthesia, Herlev Hospital, University of Copenhagen, Denmark.
Anesthesiology. 1993 Mar;78(3):436-44. doi: 10.1097/00000542-199303000-00006.
Although pulse oximetry is currently in widespread use, there are few data documenting improvement in patient outcome as a result of the use of oximetry. The authors describe the study design, patient demographic findings, data validation, pulse oximetry failure rate, and overall postoperative complication rates in the first large prospective randomized multicenter clinical trial on perioperative pulse oximetry monitoring.
In five Danish hospitals, by random assignment, monitoring did or did not include pulse oximetry for patients 18 yr of age and older, whether scheduled for elective or emergency operations, or for regional or general anesthesia, except during cardiac and neurosurgical procedures. Operational definitions were established for perioperative events and postoperative complications. The data were collected preoperatively, during anesthesia, in the postanesthesia care unit, and until the day of discharge from the hospital or the seventh postoperative day.
Of 20,802 patients, 10,312 were assigned to the oximetry group and 10,490, to the control group. In general, the demographic data, patient factors, and anesthetic agents used were distributed evenly. A slight intergroup difference was found in the distribution of age, duration of surgery, some types of surgery, and some types of anesthesia. The total failure rate of the oximetry was 2.5%, but it increased to 7.2% in patients with American Society of Anesthesiologists physical status 4 (P < 0.00001). In 14.9% of the patients, one or more events occurred in the operating room and 13.5% in the postanesthesia care unit. The overall postoperative complication rate was 9.7%. The total rates of cardiovascular and respiratory complications were 2.78% and 3.50%, respectively. Within the first seven postoperative days, 0.47% of the patients died. Anesthesia was not thought to have been solely responsible for any death, but in 7 patients (1 per 3,365), it was a possible contributory factor.
Despite the finding of a few significant inter-group differences, the randomization was well balanced with a high validity of data. The overall postoperative complication rate was similar to that in other recent morbidity and mortality studies.
尽管脉搏血氧饱和度测定法目前已被广泛使用，但几乎没有数据能证明使用该方法可改善患者预后。作者在第一项关于围手术期脉搏血氧饱和度监测的大型前瞻性随机多中心临床试验中，描述了研究设计、患者人口统计学结果、数据验证、脉搏血氧饱和度测定失败率以及总体术后并发症发生率。
在丹麦的五家医院，通过随机分配，对18岁及以上患者的监测包括或不包括脉搏血氧饱和度测定，无论患者是计划进行择期手术还是急诊手术，接受区域麻醉还是全身麻醉，但心脏和神经外科手术期间除外。为围手术期事件和术后并发症制定了操作定义。数据在术前、麻醉期间、麻醉后护理单元以及直至出院日或术后第七天收集。
20802例患者中，10312例被分配到血氧饱和度测定组，10490例被分配到对照组。总体而言，人口统计学数据、患者因素和使用的麻醉剂分布均匀。在年龄分布、手术持续时间、某些类型的手术和某些类型的麻醉方面发现了轻微的组间差异。脉搏血氧饱和度测定的总失败率为2.5%，但美国麻醉医师协会身体状况分级为4级的患者中，失败率增至7.2%（P<0.00001）。14.9%的患者在手术室发生了一次或多次事件，13.5%的患者在麻醉后护理单元发生了此类事件。总体术后并发症发生率为9.7%。心血管和呼吸系统并发症的总发生率分别为2.78%和3.50%。术后头七天内，0.47%的患者死亡。未认为麻醉完全导致任何死亡，但在7例患者中（每3365例中有1例），麻醉可能是一个促成因素。
尽管发现了一些显著的组间差异，但随机分组平衡良好，数据有效性高。总体术后并发症发生率与近期其他发病率和死亡率研究中的发生率相似。
