Status:
COMPLETED
Navigation System for Percutaneous Tracheotomy
Lead Sponsor:
Karolinska University Hospital
Conditions:
Ventilation Therapy; Complications
Tracheostomy Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
We have studied a new technique for percutaneous tracheotomy. The instrument gives a three dimensional positioning of the puncture. The technique is used on patients on ENT surgery and intensiv care.
Detailed Description
Percutaneous tracheotomy is a well-established method. Anatomical landmarks need to be identified. We introduce a new method that increases precision through three-dimensional navigation with a new in...
Eligibility Criteria
Inclusion
- Patients age \>18 years old
- Patients requiring PDT for prolonged mechanical ventilation, airway protection or weaning failure
Exclusion
- Pediatric patients
- Emergency tracheotomies
- Anatomical abnormalities due to hematoma/tumor/scarring from previous neck surgery/thyromegaly/unstable C-spine and difficult local anatomy. (Patients with obesity are not considered to be a hindrance for the SafeTrach technique as the location for puncture easily can be decided with help of the outer and inner shanks).
- Contra indication for re-intubation (suspected loss of airway during re-intubation)
- Coagulation abnormalities - INR\>1.5, PTT \>40, thrombocyte count \<50.000
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04744909
Start Date
March 1 2017
End Date
August 11 2020
Last Update
February 9 2021
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Solna, Sweden, 171 64