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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01722981
Enrollment
300
Registered
2012-11-07
Start date
2013-01-31
Completion date
2016-01-31
Last updated
2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Tracheostomy Complication

Brief 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.

Interventions

Three methods of percutaneous tracheostomy

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Systematic comparison3 yearsa systematic comparison among the three methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity and mortality, up to 30 days.

Secondary

MeasureTime frameDescription
Minor morbidity3 yearsMinor 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026