Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: Prospective Study
NCT ID: NCT01722981
Last Updated: 2012-11-14
Study Results
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2013-01-31
2016-01-31
Brief Summary
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In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.
Using technological aids, such as direct sonography and bronchoscopy in real time may significantly reduce the rate of complications as a result of performing percutaneous tracheostomy.
So far, no systematic comparison has been made among the three methods.
Detailed Description
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Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In many places around the world it is customary in to perform the operation under the guidance of a bronchoscope to prevent damage to adjacent structures, high or low position of the tube, and damage to the posterior wall of the trachea and to approve the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment, knowledge of the operator, temporary occlusion of the trachea and hypercarbia, increased length of the procedure, and maintenance cost (disinfection, replacement, etc.).
Ultrasound that is performed before percutaneous procedure may be useful in preventing damage to para tracheal adjacent structures, and preventing high placement of the tube. The use of duplex sonography with real-time visualization of the needle path is done routinely in procedures such as central venous catheterization, and may improve the safety and accuracy of percutaneous tracheostomy without causing airway obstruction or hypercarbia. Feasibility of the procedure has been reviewed in an article by Rajajee et al .
In our institution as in a number of institutions in the country, it is acceptable to perform the operation by placing the tube on a high position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by palpation of the neck.
So far, no systematic comparison has been made among the three methods.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Direct laryngoscopy
Performing percutaneous tracheostomy as accepted in our institute: By placing the tube higher up near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck.
Percutaneous tracheostomy
Three methods of percutaneous tracheostomy
Real time sonography
Percutaneous tracheostomy will be guided by real time sonography (with the visualization of the needle path) using acoustic shadows of the cricoid and the tracheal rings.
In both methods, in order to identify the anatomic location of the needle prick- after passing the guide wire, the front elevation will be verified by optical means, which will be drawn out immediately afterwards.
Percutaneous tracheostomy
Three methods of percutaneous tracheostomy
Bronchoscopy
Percutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire.
Percutaneous tracheostomy
Three methods of percutaneous tracheostomy
Interventions
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Percutaneous tracheostomy
Three methods of percutaneous tracheostomy
Eligibility Criteria
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Inclusion Criteria
* Minimal age 18
Exclusion Criteria
* Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room.
18 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Patrick Sorkine, professor
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Facility Contacts
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Akiva Nachshon, MD
Role: primary
Other Identifiers
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TASMC-12-PS-0408-12-CTIL
Identifier Type: -
Identifier Source: org_study_id