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

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ClinicalTrials.gov Identifier: NCT06018220
Recruitment Status : Recruiting
First Posted : August 30, 2023
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Birgitte Majholm, Rigshospitalet, Denmark

Study Description
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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
Tracheostomy Complication

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
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Study Type : Observational
Estimated 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 : June 27, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with complications following tracheostomy [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: Up to 6 months following tracheostomy ]
    Non-skilled residents vs. senior physician

  2. Days [ Time Frame: Up to 6 months ]
    Time from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patientiens in Neurointensive Care. Diagnosis are: Traumatic brain injury, intracranial haemorrhage, subarachoid haemorrahge, spinal cord injury, guillian barre, myastenia gravis, status epilepticus, postoperative conditions.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06018220


Contacts
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Contact: Martin K soerensen, PHD +45 35457009 Martin.Kryspin.Soerensen.01@regionh.dk
Contact: Martin K Soerensen, PHD + 45 3545 7009 Martin.Kryspin.Soerensen.01@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Martin Kryspin Soerensen, PHD    +45 35457009    Martin.Kryspin.Soerensen.01@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Martin K Soerensen, PHD Department of Neruoanaesthesiology
More Information
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Responsible Party: Birgitte Majholm, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT06018220    
Other Study ID Numbers: NEU6021
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: February 23, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No