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.

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.

Study Overview

• Status: Unknown
• Conditions: Other Tracheostomy Complication
• Intervention / Treatment: Procedure: Percutaneous tracheostomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
• Minimal age 18

Exclusion Criteria:

• No patient consent for participation.
• Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Percutaneous tracheostomy; Three methods of percutaneous tracheostomy
Active Comparator: 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.	Procedure: Percutaneous tracheostomy; Three methods of percutaneous tracheostomy
Active Comparator: 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.	Procedure: Percutaneous tracheostomy; Three methods of percutaneous tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systematic comparison	a systematic comparison among the three methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity and mortality, up to 30 days.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor morbidity	Minor morbidity among patients, and a comparison between the in-house patients to the rest of hospitalized patients that come to the unit for the procedure, according to the same criteria.	3 years

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Patrick Sorkine, professor, Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: November 4, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: TASMC-12-PS-0408-12-CTIL