Navigation System for Percutaneous Tracheotomy

Not Applicable

Completed

• Conditions: Tracheostomy Complication; Ventilation Therapy; Complications
• Interventions: Device: SafeTrach for tracheotomy

• Registration Number: NCT04744909
• Lead Sponsor: Karolinska University Hospital

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 instrument - SafeTrach.

SafeTrach is a pliers-like instrument. The inner shank acts as a ventilation tube while stabilizing the orotracheal tube in the trachea. The outer shank acts as a three-dimensional control instrument for the puncture needle.

We determined the puncture level in 20 patients using SafeTrach. We found that the distance from the vocal cords to the puncture site was about 45 mm for men and 42 mm for women. This was based on intraoperative measurements. In 13 patients, we studied the distance between the vocal cords and the optimal puncture site between the 2nd and 3rd tracheal ring with CT and found that the mean distance for men was 49.8 mm and for women 42.2 mm. We have used internal measurements in another 12 patients as follows: The orotracheal tube is positioned so that the proximal part of the cuff is just below the vocal cords. 2. The position of the tube is measured against the front teeth. 3. The orotracheal tube together with the inner shank is pulled up about 15 mm for both men and women. This means that part of the cuff lies between the vocal cords and you get an acceptable placement of the puncture needle.

By using SafeTrach you can use internal landmarks to indicate the puncture level. The positioning of the leg is done with high precision because SafeTrach acts as a stable guide. The navigation system minimizes the risk of extubation and damage to the posterior tracheal wall.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-05
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients age >18 years old
• Patients requiring PDT for prolonged mechanical ventilation, airway protection or weaning failure

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous tracheotomy using a new device	SafeTrach for tracheotomy	-

Primary Outcome Measures

Name	Time	Method
Navigation System for Percutaneous Tracheotomy	30 minutes	Precision of puncture site

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Solna, Sweden