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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT06018220
Collaborator
(none)
383
1
6.2
62

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    383 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study
    Actual Study Start Date :
    Jun 27, 2023
    Anticipated Primary Completion Date :
    Aug 20, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with complications following tracheostomy [Up to 1 week after tracheostomy procedure]

      Bleeding; pneumothorax, pneumomediastinum, lost airway, via falsa, procedure-related death, other.

    2. Number of patients with complications following tracheostomy - long term. [From 1 week up to 6 months after the tracheostomy procedure]

      Tracheal stenosis, fistula, wound infection, accidental decannulation, scarring, delayed wound healing, changes in voice or speech, other.

    Secondary Outcome Measures

    1. Number of complications according to the skilled level of the clinician performing the tracheostomy (only for percutaneous dilatational tracheostomy) [Up to 6 months following tracheostomy]

      Non-skilled residents vs. senior physician

    2. Days [Up to 6 months]

      Time from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Study Chair: Martin K Soerensen, PHD, Department of Neruoanaesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Birgitte Majholm, Principal Investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT06018220
    Other Study ID Numbers:
    • NEU6021
    First Posted:
    Aug 30, 2023
    Last Update Posted:
    Aug 30, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 30, 2023