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Ultrasound Guided Percutaneous Tracheostomy

Primary Purpose

Tracheostomy Hemorrhage, Tracheostomy Complications, Other Tracheostomy Complications

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Ultrasonography (EnVisor Philips Medical Systems)

About this trial

This is an interventional supportive care trial for Tracheostomy Hemorrhage focused on measuring percutaneous tracheostomy, ultrasonography, echography, critical care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients hospitalized in ICU in whom percutaneous tracheostomy is indicated,
patients aged > 18 years old,

Exclusion Criteria:

age less than 18 years,
clotting disorder,
infection at the puncture site,
emergency tracheostomy

Sites / Locations

CHU Amiens

Outcomes

Primary Outcome Measures

Procedure related complications

Complications are: paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma.

Secondary Outcome Measures

Procedure time

The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy.

Full Information

NCT ID

NCT01502657

First Posted

April 21, 2011

Last Updated

December 30, 2011

Sponsor

Centre Hospitalier Universitaire, Amiens

1. Study Identification

Unique Protocol Identification Number

NCT01502657

Brief Title

Ultrasound Guided Percutaneous Tracheostomy

Official Title

Ultrasound Guided Percutaneous Tracheostomy in the ICU

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

Detailed Description

Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tracheostomy Hemorrhage, Tracheostomy Complications, Other Tracheostomy Complications

Keywords

percutaneous tracheostomy, ultrasonography, echography, critical care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Ultrasonography (EnVisor Philips Medical Systems)

Other Intervention Name(s)

Echograph is EnVisor Philips, N°453561299512 rev A, CE0086

Intervention Description

Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;

Primary Outcome Measure Information:

Title

Procedure related complications

Description

Time Frame

At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcome Measure Information:

Title

Procedure time

Description

The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy.

Time Frame

The time will be calculated at the end of the procedure; an average of 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients hospitalized in ICU in whom percutaneous tracheostomy is indicated, patients aged > 18 years old, Exclusion Criteria: age less than 18 years, clotting disorder, infection at the puncture site, emergency tracheostomy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre grégoire Guinot, MD

Organizational Affiliation

Centre Hospitalier Universitaire, Amiens

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens

City

Amiens

State/Province

Somme

ZIP/Postal Code

80000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

22390815

Citation

Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.

Results Reference

derived

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Ultrasound Guided Percutaneous Tracheostomy

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