Postoperative Inflammation and Recovery After Tracheostomy

NCT02096640 — Not applicable, Unknown, 150 participants, Sormland County Council, Sweden

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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.

Registry	NCT02096640
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	Sormland County Council, Sweden (Other)
Conditions	Tracheostomy Complication, Inflammation, Post-operative Complications
Interventions	Type of surgical teqnique for tracheostomy (Procedure)
Dates	start 2014-03-01, primary completion 2018-12-01 (estimated), completion 2019-12-01 (estimated), first posted 2014-03-26, last updated 2014-03-26
Locations	1 site in Sweden

-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.

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+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)?

+Arms and interventions

Arm	Type	Interventions	Description
Percutaneous dilatation tracheostomy: Smiths Medical	Active comparator	Procedure: 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	Active comparator	Procedure: Type of surgical teqnique for tracheostomy	Type of surgical teqnique for tracheostomy: Open surgical tracheostomy

Type of surgical teqnique for tracheostomy (Procedure)

+Outcome measures

Primary outcomes

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 outcomes

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.

Other outcomes

Physical function [One week after tracheostomy]: Notes 7 Days after tracheostomy on the time to mobilization to sitting, standing and walking, respectively.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Intensivvårdsavdelningen på Mälarsjukhuset	Eskilstuna, Sörmland	Sweden

+Investigators

Markus Castegren, MD, PhD, Principal investigator, Centre for Clinical Research, Uppsala University