NCT01502657

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

April 21, 2011

Last Update Submit

September 16, 2025

Conditions

Tracheostomy HemorrhageTracheostomy ComplicationsOther Tracheostomy Complications

Keywords

percutaneous tracheostomyultrasonographyechographycritical care

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Procedure time

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

Interventions

Ultrasonography (EnVisor Philips Medical Systems)DEVICE

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

Also known as: Echograph is EnVisor Philips, N°453561299512 rev A, CE0086

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, Somme, 80000, France

Location

Related Publications (1)

  • 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.

    PMID: 22390815RESULT

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Pierre grégoire Guinot, MD

    Centre Hospitalier Universitaire, Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

January 2, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)