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

NCT06018220 | Recruiting DMC

• 1 other identifier: NEU6021
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Complication

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

• Days

  Up to 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Children - age \< 18.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Study Officials

• Martin K Soerensen, PHD

  Department of Neruoanaesthesiology

  STUDY CHAIR

Central Study Contacts

Martin K soerensen, PHD

CONTACT

+45 35457009; Martin.Kryspin.Soerensen.01@regionh.dk

Martin K Soerensen, PHD

CONTACT

+ 45 3545 7009; Martin.Kryspin.Soerensen.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 30, 2023
• Study Start: June 27, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)