Postoperative Inflammation and Recovery After Tracheostomy

NCT ID: NCT02096640

Last Updated: 2014-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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)?

Conditions

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Tracheostomy Complication Inflammation Post-operative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Type of surgical teqnique for tracheostomy

Intervention Type PROCEDURE

Open surgery tracheostomy

Type of surgical teqnique for tracheostomy: Open surgical tracheostomy

Group Type ACTIVE_COMPARATOR

Type of surgical teqnique for tracheostomy

Intervention Type PROCEDURE

Interventions

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Type of surgical teqnique for tracheostomy

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

Children under 18 years, pregnancy and participants with anatomical defects that exclude them from percutaneous dilatation tracheostomy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sormland County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Markus Castegren

Med. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Castegren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Clinical Research, Uppsala University

Locations

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Intensivvårdsavdelningen på Mälarsjukhuset

Eskilstuna, Sörmland, Sweden

Site Status

Countries

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Sweden

Central Contacts

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Ulrika H Skoog, PTh

Role: CONTACT

016-104570

Markus Castegren, MD, PhD

Role: CONTACT

016-105737

Other Identifiers

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2013/1136-31/2LTS

Identifier Type: OTHER

Identifier Source: secondary_id

2013/1136-31/2

Identifier Type: -

Identifier Source: org_study_id

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