NCT01722981

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

3 years

First QC Date

November 4, 2012

Last Update Submit

November 13, 2012

Conditions

Other Tracheostomy Complication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Minor morbidity

    3 years

Study Arms (3)

Direct laryngoscopy

ACTIVE COMPARATOR

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

Real time sonography

ACTIVE COMPARATOR

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

Bronchoscopy

ACTIVE COMPARATOR

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

Interventions

Percutaneous tracheostomyPROCEDURE

Three methods of percutaneous tracheostomy

BronchoscopyDirect laryngoscopyReal time sonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Study Officials

  • Patrick Sorkine, professor

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2012

First Posted

November 7, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

IL(1)