Navigation System for Percutaneous Tracheotomy

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.

Study Overview

• Status: Completed
• Conditions: Ventilation Therapy; Complications; Tracheostomy Complication
• Intervention / Treatment: Device: SafeTrach for tracheotomy

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Solna
    • Stockholm, Solna, Sweden, 171 64
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous tracheotomy using a new device	Device: SafeTrach for tracheotomy; The navigation system is a forceps-like instrument with an outer and an inner shank. The inner shank serves as a ventilation lumen and stabilizes the orotracheal tube in the midline of trachea. The outer shank acts as a three-dimensional guide for the puncturing needle to the midline of trachea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navigation System for Percutaneous Tracheotomy	Precision of puncture site	30 minutes

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Jonas Karling, Ph.D, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 11, 2020
• Study Completion (Actual): August 11, 2020

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: intensive care; Tracheotomy; tracheostomy; percutaneous dilatational tracheotomy
• Other Study ID Numbers: SafeTrach 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No