Postoperative Inflammation and Recovery After Tracheostomy

Sormland County Council, Sweden

Status: Unknown

Conditions: Inflammation; Tracheostomy Complication; Post-operative Complications

Treatments: Procedure: Type of surgical teqnique for tracheostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02096640

2013/1136-31/2

2013/1136-31/2LTS (Other Identifier)

Details and patient eligibility

About

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.

Full 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)?

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Percutaneous dilatation tracheostomy: Smiths Medical

Active Comparator group

Description:

Type of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM.

Treatment:

Procedure: Type of surgical teqnique for tracheostomy

Open surgery tracheostomy

Active Comparator group

Description:

Type of surgical teqnique for tracheostomy: Open surgical tracheostomy

Treatment:

Procedure: Type of surgical teqnique for tracheostomy