PERCUTANEOUS DILATATIONAL TRACHEOSTOMY VERSUS CONVENTIONAL SURGICAL TRACHEOSTOMY - A CLINICAL RANDOMIZED STUDY

Background: As no clinical randomised studies have previously been per formed comparing complications with the Ciaglia Percutaneous Dilatatio nal Tracheostomy Introducer Set (PDT) and conventional surgical trache ostomy (TR), we designed a study with the aim of comparing the efficac y and safety of the two techniques. Methods: Sixty patients selected f or elective tracheostomy were randomised for either PDT (30 patients) or TR (30 patients). All patients had general anaesthesia and were ven tilated with 100% oxygen. Furthermore, lidocaine with epinephrine 1% ( 3-5 ml) was used for local analgesia and to minimise bleeding during t he procedure. Results: The median time for insertion of the tracheosto my tube was 11.5 min (range 7-24 min) in the PDT group and 15 min (ran ge 5-47 min) in the TR group (P<0.01). Complications during the proced ure 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 o pposed to 24 cases in the TR group (P<0.01), major bleeding in none ve rsus 2 cases, respectively. In 8 cases in the PDT group, increased res istance to insertion of the tracheostomy tube was met by further dilat ation. During the post-tracheostomy period, complications occurred wit h 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 g roup 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). Conclus ion: Our results indicate that the percutaneous dilatational tracheost omy technique performed with the Ciaglia Introducer Set is effective, safe and superior to conventional surgical tracheostomy as immediate c omplications as well as complications with the tracheostomy tube in si tu are fewer and of less severity.