Holdgaard H O, Pedersen J, Jensen R H, Outzen K E, Midtgaard T, Johansen L V, Møller J, Paaske P B
Department of Anaesthesia, University Hospital of Aarhus/Skejby, Denmark.
Acta Anaesthesiol Scand. 1998 May;42(5):545-50. doi: 10.1111/j.1399-6576.1998.tb05164.x.
As no clinical randomised studies have previously been performed comparing complications with the Ciaglia Percutaneous Dilatational Tracheostomy Introducer Set (PDT) and conventional surgical tracheostomy (TR), we designed a study with the aim of comparing the efficacy and safety of the two techniques.
Sixty patients selected for elective tracheostomy were randomised for either PDT (30 patients) or TR (30 patients). All patients had general anaesthesia and were ventilated with 100% oxygen. Furthermore, lidocaine with epinephrine 1% (3-5 ml) was used for local analgesia and to minimise bleeding during the procedure.
The median time for insertion of the tracheostomy tube was 11.5 min (range 7-24 min) in the PDT group and 15 min (range 5-47 min) in the TR group (P<0.01). Complications during the procedure were cuff puncture of the endotracheal tube in 5 cases in the PDT group. Minor bleeding was encountered in 6 cases in the PDT group as opposed to 24 cases in the TR group (P<0.01), major bleeding in none versus 2 cases, respectively. In 8 cases in the PDT group, increased resistance to insertion of the tracheostomy tube was met by further dilatation. During the post-tracheostomy period, complications occurred with minor bleeding in 2 cases in the PDT group as opposed to 9 cases in the TR group (P<0.05), and major bleeding was encountered in 1 case in each group. Minor infections were encountered in 3 cases in the PDT group as opposed to 11 cases in the TR group (P<0.01). Major infection was encountered in none versus 8 cases, respectively (P<0.01).
Our results indicate that the percutaneous dilatational tracheostomy technique performed with the Ciaglia Introducer Set is effective, safe and superior to conventional surgical tracheostomy as immediate complications as well as complications with the tracheostomy tube in situ are fewer and of less severity.
由于此前尚无临床随机研究比较使用Ciaglia经皮扩张气管切开导入套件（PDT）与传统外科气管切开术（TR）的并发症情况，我们设计了一项研究，旨在比较这两种技术的疗效和安全性。
选取60例行择期气管切开术的患者，随机分为PDT组（30例）和TR组（30例）。所有患者均接受全身麻醉，并用100%氧气通气。此外，使用1%利多卡因加肾上腺素（3 - 5毫升）进行局部镇痛，并尽量减少手术过程中的出血。
PDT组气管切开管插入的中位时间为11.5分钟（范围7 - 至），TR组为15分钟（范围5 - 47分钟）（P<0.01）。手术过程中的并发症包括：PDT组有5例气管内导管套囊穿刺；PDT组有6例出现少量出血，而TR组有24例（P<0.01），PDT组无大出血，TR组有2例；PDT组有8例在进一步扩张时遇到气管切开管插入阻力增加。气管切开术后，PDT组有2例出现少量出血并发症，TR组有9例（P<0.05），两组各有1例出现大出血。PDT组有3例出现轻微感染，TR组有11例（P<0.01）。两组分别无严重感染和有8例严重感染（P<0.01）。
我们的结果表明，使用Ciaglia导入套件进行的经皮扩张气管切开术有效、安全，且优于传统外科气管切开术，因为其即时并发症以及气管切开管在位时的并发症更少且严重程度更低。
