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| ID | Type | Description | Link |
|---|---|---|---|
| 2013/1136-31/2LTS | Other Identifier | Sormlands Landsting |
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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.
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)?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous dilatation tracheostomy: Smiths Medical | Active Comparator | Type of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM. |
|
| Open surgery tracheostomy | Active Comparator | Type of surgical teqnique for tracheostomy: Open surgical tracheostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of surgical teqnique for tracheostomy | Procedure |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | Notes 7 Days after tracheostomy on the time to mobilization to sitting, standing and walking, respectively. | One week after tracheostomy |
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ulrika H Skoog, PTh | Contact | 016-104570 | ulrika.skoog@dll.se | |
| Markus Castegren, MD, PhD | Contact | 016-105737 | markus.castegren@dll.se |
| Name | Affiliation | Role |
|---|---|---|
| Markus Castegren, MD, PhD | Centre for Clinical Research, Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensivvårdsavdelningen på Mälarsjukhuset | Eskilstuna | Sörmland | 631 88 | Sweden |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014139 | Tracheostomy |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
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| D013517 |
| Otorhinolaryngologic Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |