Postoperative Inflammation and Recovery After Tracheostomy
Randomized Controlled Trial on the Effect of Percutaneous Dilatation Tracheostomy Compared to Open Surgical Tracheostomy on Postoperative Inflammation, Pulmonary Function, Peri- and Postoperative Complications and Physical Mobilization.
2 other identifiers
interventional
150
1 country
1
Brief Summary
The main purpose of this study is to examine if there are differences in postoperative inflammation following percutaneous dilatation tracheostomy versus surgical tracheostomy in intensive care unit patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 26, 2014
March 1, 2014
4.8 years
March 13, 2014
March 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in inflammation markers in plasma
Plasma samples will be taken preoperative and 24 hours after the start of tracheostomy. The levels of TNF-alpha, IL-6 and IL-10 will be measured.
Preoperative and 24 hours after the start of surgery
Secondary Outcomes (1)
Postoperative complications
Until discharge from the ICU
Other Outcomes (1)
Physical function
One week after tracheostomy
Study Arms (2)
Percutaneous dilatation tracheostomy: Smiths Medical
ACTIVE COMPARATORType of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM.
Open surgery tracheostomy
ACTIVE COMPARATORType of surgical teqnique for tracheostomy: Open surgical tracheostomy
Interventions
Eligibility Criteria
You may not qualify if:
- Children under 18 years, pregnancy and participants with anatomical defects that exclude them from percutaneous dilatation tracheostomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intensivvårdsavdelningen på Mälarsjukhuset
Eskilstuna, Sörmland, 631 88, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Castegren, MD, PhD
Centre for Clinical Research, Uppsala University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Med. dr.
Study Record Dates
First Submitted
March 13, 2014
First Posted
March 26, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
March 26, 2014
Record last verified: 2014-03