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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheostomy Complication
- Sponsor
- Sormland County Council, Sweden
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in inflammation markers in plasma
- Last Updated
- 12 years ago
Overview
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)?
Investigators
Markus Castegren
Med. dr.
Sormland County Council, Sweden
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in inflammation markers in plasma
Time Frame: 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 Outcomes
- Postoperative complications(Until discharge from the ICU)