Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06018220 |
Recruitment Status :
Recruiting
First Posted : August 30, 2023
Last Update Posted : February 23, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Tracheostomy Complication |
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 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 |
- 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.
- 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.
- 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
- Days [ Time Frame: Up to 6 months ]Time from admission to tracheostomy, time to decannulation, time to discharge from ICU/hospital
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
Patients admitted to Neurointensive Care Unit, Rigshospitalet, Denmark AND having a tracheostomy performed during their stay.
-
Exclusion Criteria:
Children - age < 18.
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
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 |
Denmark | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark | |
Contact: Martin Kryspin Soerensen, PHD +45 35457009 Martin.Kryspin.Soerensen.01@regionh.dk |
Study Chair: | Martin K Soerensen, PHD | Department of Neruoanaesthesiology |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |