NCT06018220

Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 383 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present quality study is to examine the relationship between choice of tracheotomy procedure and complications in a neurocritically ill patient population at a single center. Secondary outcomes are the influence of clinician skill level (for PDTs), time from admission to tracheostomy, length of stay and time to decannulation.

Detailed description

Neurocritically ill patients often require placement of a tracheostomy at some point during admission, as impaired consciousness and insufficient protective airway reflexes often make weaning from mechanical ventilation prolonged. Percutaneous dilatational tracheostomy (PDT) with fiberoptic visualization can be performed bedside by neurointensivists or residents under supervision, unless there are contraindications. However, concerns regarding tracheal stenosis following PDT have been raised. This a rare complication but when it occurs it is a severe long-term complication, and the patients are often in need of repeated interventions. The alternative is surgical tracheostomy (ST) which is more resource intensive but perceived as safer in high risk patients. The indication for tracheostomy (and the choice of procedure) is ultimately based on judgement of clinical team. Systematic reviews have found no difference between PDT and ST regarding severe complications, apart from a higher incidence of wound infections after ST. However, a higher incidence of complications following PDT has been reported when residents are performing the procedure, suggesting an influence of physician skill level. Methods: This is a retrospective observational single-center quality study. All patients \> 18 years of age admitted to the Neurointensive Care Unit at Rigshospitalet, Copenhagen between January 2018 and December 2022 with a registered procedure code for either PDT or ST wil be included. Approval from departmental leadership and The Judicial Department at Rigshopitalet has been attained. Data will be extracted from the electronical medical records and any short (\< 1 week) or long-term complications will be registered. The follow-up period is 6 months.

Conditions

• Tracheostomy Complication

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-08-30
• Last updated: 2024-02-23

Locations

1 site across 1 country: Denmark