Postoperative Inflammation and Recovery After Tracheostomy

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.

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Tracheostomy Complication; Post-operative Complications
• Intervention / Treatment: Procedure: Type of surgical teqnique for tracheostomy

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Sörmland
    • Eskilstuna, Sörmland, Sweden, 631 88
      • Intensivvårdsavdelningen på Mälarsjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous dilatation tracheostomy: Smiths Medical; Type of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM.	Procedure: Type of surgical teqnique for tracheostomy
Active Comparator: Open surgery tracheostomy; Type of surgical teqnique for tracheostomy: Open surgical tracheostomy	Procedure: Type of surgical teqnique for tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sormland County Council, Sweden
• Investigators: Principal Investigator: Markus Castegren, MD, PhD, Centre for Clinical Research, Uppsala University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 23, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 23, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Postoperative Complications
• Other Study ID Numbers: 2013/1136-31/2; 2013/1136-31/2LTS (Other Identifier: Sormlands Landsting)