Percutaneous Tracheostomy - Systematic Comparison Among Two Methods
1 other identifier
interventional
300
0 countries
N/A
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 the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance. So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedJune 16, 2016
April 1, 2016
2.8 years
April 13, 2016
June 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
A systematic comparison among the two methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity.
30 days
Secondary Outcomes (4)
Periprocedural Mortality.
30 days.
Post procedural ICU & Hospital length of stay.
30 days.
Complication rate comparison of PDT done in the ICU to PDT done in locations other than the ICU.
30 days.
Procedure's length.
60 minutes
Study Arms (2)
Bronchoscopy Guided
OTHERPercutaneous 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.
Direct Laryngoscopy
OTHERPerforming percutaneous tracheostomy 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.
Interventions
Eligibility Criteria
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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2016
First Posted
June 16, 2016
Study Start
July 1, 2016
Primary Completion
May 1, 2019
Last Updated
June 16, 2016
Record last verified: 2016-04