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UnknownNCT01722981

Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: Prospective Study

Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: US-guided Tracheostomy, Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
Tel-Aviv Sourasky Medical Center · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room. 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

Percutaneous tracheostomy is routinely performed in most intensive care units in the world in a number of indications, such as: airway obstruction, need for a long respiratory support, improvement in respiratory toilet, prophylaxis before head and neck procedures and cases of severe obstructive sleep apnea. 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

Interventions

TypeNameDescription
PROCEDUREPercutaneous tracheostomyThree methods of percutaneous tracheostomy

Timeline

Start date
2013-01-01
Primary completion
2016-01-01
Completion
2016-01-01
First posted
2012-11-07
Last updated
2012-11-14

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01722981. Inclusion in this directory is not an endorsement.