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

NCT ID: NCT06018220

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 383 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2024-06-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Patients admitted to Neurointensive Care Unit, Rigshospitalet, Denmark AND having a tracheostomy performed during their stay.

-

Exclusion Criteria

Children - age < 18.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Birgitte Majholm

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin K Soerensen, PHD

Role: STUDY_CHAIR

Department of Neruoanaesthesiology

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Martin K soerensen, PHD

Role: CONTACT

Martin.Kryspin.Soerensen.01@regionh.dk

+45 35457009

Martin K Soerensen, PHD

Role: CONTACT

Martin.Kryspin.Soerensen.01@regionh.dk

+ 45 3545 7009

Facility Contacts

Martin Kryspin Soerensen, PHD

Role: primary

Martin.Kryspin.Soerensen.01@regionh.dk

+45 35457009

Other Identifiers

NEU6021

Identifier Type: -

Identifier Source: org_study_id