Postoperative Inflammation and Recovery After Tracheostomy

Study Overview
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Brief Summary
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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
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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)?

Official Title
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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.

Conditions
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Tracheostomy Complication, Inflammation, Post-operative Complications

Intervention / Treatment
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* Procedure: Type of surgical teqnique for tracheostomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous dilatation tracheostomy: Smiths Medical<br>Type of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM. | Procedure: Type of surgical teqnique for tracheostomy<br> <br> |
| Active Comparator: Open surgery tracheostomy<br>Type of surgical teqnique for tracheostomy: Open surgical tracheostomy | Procedure: Type of surgical teqnique for tracheostomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | All postoperative complications will be noted daily during the ICU-stay, i.e. bleeding, incidence of stomal infections, tracheal tube dislocation, airway compromisation. | Until discharge from the ICU |