Inflammation, Post-operative Complications, Tracheostomy Complication
Conditions
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.
Detailed description
Are there differences between the two arms in plasma concentrations of inflammatory mediators (TNF-alfa, interleukin 1, 6, 10) at 24 hrs following the start of the surgical procedure? Are there differences between the two arms in the incidence of postoperative complications (i.e. bleeding, incidence of stomal infections, tracheal tube dislocation, airway compromisation), postoperative pulmonary infection (during the stay in the ICU) and pulmonary function (FEV1, dynamic complicance, oxygen demand, time to weaning off the ventilator: all measured daily during the ICU-stay), postoperative mobilization (time to mobilization to sitting, standing and walking, respectively)?
Interventions
PROCEDUREType of surgical teqnique for tracheostomy
Sponsors
Sormland County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients in whom a tracheostomy is indicated (i.e. anticipated need of mechanical ventilation for \>7 days or anticipated risk for complicated extubation, e.g. anatomical signs of a compromised airway, reduced level of consciousness. Adults over 18 years. Participants who are suitable for both surgery techniques.
Exclusion criteria
Children under 18 years, pregnancy and participants with anatomical defects that exclude them from percutaneous dilatation tracheostomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammation markers in plasma | Preoperative and 24 hours after the start of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Until discharge from the ICU | All postoperative complications will be noted daily during the ICU-stay, i.e. bleeding, incidence of stomal infections, tracheal tube dislocation, airway compromisation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical function | One week after tracheostomy | Notes 7 Days after tracheostomy on the time to mobilization to sitting, standing and walking, respectively. |
Countries
Sweden
Contacts
Primary ContactUlrika H Skoog, PTh
Backup ContactMarkus Castegren, MD, PhD
Outcome results
None listed