Postoperative Inflammation and Recovery After Tracheostomy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Sormland County Council, Sweden
Sponsor:
Information provided by (Responsible Party):
Markus Castegren, Sormland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT02096640
First received: March 13, 2014
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Tracheostomy Complication
Inflammation
Post-operative Complications
Procedure: Type of surgical teqnique for tracheostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sormland County Council, Sweden:

Primary Outcome Measures:
  • Change in inflammation markers in plasma [ Time Frame: Preoperative and 24 hours after the start of surgery ] [ Designated as safety issue: No ]
    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:
  • Postoperative complications [ Time Frame: Until discharge from the ICU ] [ Designated as safety issue: Yes ]
    All postoperative complications will be noted daily during the ICU-stay, i.e. bleeding, incidence of stomal infections, tracheal tube dislocation, airway compromisation.


Other Outcome Measures:
  • Physical function [ Time Frame: One week after tracheostomy ] [ Designated as safety issue: No ]
    Notes 7 Days after tracheostomy on the time to mobilization to sitting, standing and walking, respectively.


Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096640

Contacts
Contact: Ulrika H Skoog, PTh 016-104570 ulrika.skoog@dll.se
Contact: Markus Castegren, MD, PhD 016-105737 markus.castegren@dll.se

Locations
Sweden
Intensivvårdsavdelningen på Mälarsjukhuset Not yet recruiting
Eskilstuna, Sörmland, Sweden, 631 88
Sub-Investigator: Ulrika H Skoog         
Principal Investigator: Markus Castegren, MD, PhD         
Sponsors and Collaborators
Sormland County Council, Sweden
Investigators
Principal Investigator: Markus Castegren, MD, PhD Centre for Clinical Research, Uppsala University
  More Information

No publications provided

Responsible Party: Markus Castegren, Med. dr., Sormland County Council, Sweden
ClinicalTrials.gov Identifier: NCT02096640     History of Changes
Other Study ID Numbers: 2013/1136-31/2, 2013/1136-31/2LTS
Study First Received: March 13, 2014
Last Updated: March 23, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Inflammation
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014