NCT04744909

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

February 5, 2021

Last Update Submit

February 5, 2021

Conditions

Ventilation Therapy; ComplicationsTracheostomy Complication

Keywords

Tracheotomytracheostomypercutaneous dilatational tracheotomyintensive care

Outcome Measures

Primary Outcomes (1)

  • Navigation System for Percutaneous Tracheotomy

    Precision of puncture site

    30 minutes

Study Arms (1)

Percutaneous tracheotomy using a new device

EXPERIMENTAL
Device: SafeTrach for tracheotomy

Interventions

SafeTrach for tracheotomyDEVICE

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

Percutaneous tracheotomy using a new device

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Solna, 171 64, Sweden

Location

MeSH Terms

Interventions

Tracheotomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Jonas Karling, Ph.D

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 9, 2021

Study Start

March 1, 2017

Primary Completion

August 11, 2020

Study Completion

August 11, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

SE(1)