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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06018220
Enrollment
383
Registered
2023-08-30
Start date
2023-06-27
Completion date
2024-06-01
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy Complication

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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Children - age \< 18.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with complications following tracheostomyUp to 1 week after tracheostomy procedureBleeding; pneumothorax, pneumomediastinum, lost airway, via falsa, procedure-related death, other.
Number of patients with complications following tracheostomy - long term.From 1 week up to 6 months after the tracheostomy procedureTracheal stenosis, fistula, wound infection, accidental decannulation, scarring, delayed wound healing, changes in voice or speech, other.

Secondary

MeasureTime frameDescription
Number of complications according to the skilled level of the clinician performing the tracheostomy (only for percutaneous dilatational tracheostomy)Up to 6 months following tracheostomyNon-skilled residents vs. senior physician
DaysUp to 6 monthsTime from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital

Countries

Denmark

Contacts

Primary ContactMartin K soerensen, PHD
Martin.Kryspin.Soerensen.01@regionh.dk+45 35457009
Backup ContactMartin K Soerensen, PHD
Martin.Kryspin.Soerensen.01@regionh.dk+ 45 3545 7009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026