Postoperative Inflammation and Recovery After Tracheostomy

Not Applicable

• Conditions: Tracheostomy Complication; Inflammation; Post-operative Complications
• Interventions: Procedure: Type of surgical teqnique for tracheostomy

• Registration Number: NCT02096640
• Lead Sponsor: Sormland County Council, Sweden

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)?

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-23
• Last Update Submitted: 2014-03-23
• Study First Posted: 2014-03-26
• Last Update Posted: 2014-03-26
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous dilatation tracheostomy: Smiths Medical	Type of surgical teqnique for tracheostomy	Type of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM.
Open surgery tracheostomy	Type of surgical teqnique for tracheostomy	Type of surgical teqnique for tracheostomy: Open surgical tracheostomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Intensivvårdsavdelningen på Mälarsjukhuset; 🇸🇪 Eskilstuna, Sörmland, Sweden