Postoperative Inflammation and Recovery After Tracheostomy

Inflammation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02096640
• Other study ID #: 2013/1136-31/2
• Secondary ID: 2013/1136-31/2LT
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2014
• Last updated: March 23, 2014
• Start date: March 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2014
• Source: Sormland County Council, Sweden
• Contact: Ulrika H Skoog, PTh
• Phone: 016-104570
• Email: ulrika.skoog[@]dll.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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)?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Post-operative Complications
• Postoperative Complications
• Tracheostomy Complication

Intervention

Procedure:
• Type of surgical teqnique for tracheostomy

Locations

Country	Name	City	State
Sweden	Intensivvårdsavdelningen på Mälarsjukhuset	Eskilstuna	Sörmland

Sponsors (1)

Lead Sponsor	Collaborator
Sormland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical function	Notes 7 Days after tracheostomy on the time to mobilization to sitting, standing and walking, respectively.	One week after tracheostomy	No
Primary	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	No
Secondary	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	Yes