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

Tracheostomy Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018220
• Other study ID #: NEU6021
• Status: Recruiting
• Start date: June 27, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: Martin K soerensen, PHD
• Phone: +45 35457009
• Email: Martin.Kryspin.Soerensen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 383
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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Exclusion Criteria:

Children - age < 18.

Related Conditions & MeSH terms

• Tracheostomy Complication

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complications following tracheostomy	Bleeding; pneumothorax, pneumomediastinum, lost airway, via falsa, procedure-related death, other.	Up to 1 week after tracheostomy procedure
Primary	Number of patients with complications following tracheostomy - long term.	Tracheal stenosis, fistula, wound infection, accidental decannulation, scarring, delayed wound healing, changes in voice or speech, other.	From 1 week up to 6 months after the tracheostomy procedure
Secondary	Number of complications according to the skilled level of the clinician performing the tracheostomy (only for percutaneous dilatational tracheostomy)	Non-skilled residents vs. senior physician	Up to 6 months following tracheostomy
Secondary	Days	Time from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital	Up to 6 months