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Postoperative Inflammation and Recovery After Tracheostomy

Primary Purpose

Tracheostomy Complication, Inflammation, Post-operative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Type of surgical teqnique for tracheostomy
Sponsored by
Sormland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheostomy Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Intensivvårdsavdelningen på Mälarsjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Percutaneous dilatation tracheostomy: Smiths Medical

Open surgery tracheostomy

Arm Description

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

Type of surgical teqnique for tracheostomy: Open surgical tracheostomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 13, 2014
Last Updated
March 23, 2014
Sponsor
Sormland County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02096640
Brief Title
Postoperative Inflammation and Recovery After Tracheostomy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sormland County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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)?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheostomy Complication, Inflammation, Post-operative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous dilatation tracheostomy: Smiths Medical
Arm Type
Active Comparator
Arm Description
Type of surgical teqnique for tracheostomy: Percutaneous dilatation tracheostomy. The set for the tracheostomy is bought from Smiths Medical TM.
Arm Title
Open surgery tracheostomy
Arm Type
Active Comparator
Arm Description
Type of surgical teqnique for tracheostomy: Open surgical tracheostomy
Intervention Type
Procedure
Intervention Name(s)
Type of surgical teqnique for tracheostomy
Primary Outcome Measure Information:
Title
Change in inflammation markers in plasma
Description
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.
Time Frame
Preoperative and 24 hours after the start of surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
All postoperative complications will be noted daily during the ICU-stay, i.e. bleeding, incidence of stomal infections, tracheal tube dislocation, airway compromisation.
Time Frame
Until discharge from the ICU
Other Pre-specified Outcome Measures:
Title
Physical function
Description
Notes 7 Days after tracheostomy on the time to mobilization to sitting, standing and walking, respectively.
Time Frame
One week after tracheostomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrika H Skoog, PTh
Phone
016-104570
Email
ulrika.skoog@dll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Castegren, MD, PhD
Phone
016-105737
Email
markus.castegren@dll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Castegren, MD, PhD
Organizational Affiliation
Centre for Clinical Research, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensivvårdsavdelningen på Mälarsjukhuset
City
Eskilstuna
State/Province
Sörmland
ZIP/Postal Code
631 88
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrika H Skoog
First Name & Middle Initial & Last Name & Degree
Markus Castegren, MD, PhD

12. IPD Sharing Statement

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Postoperative Inflammation and Recovery After Tracheostomy

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