NCT01793363

Brief Summary

Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration 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

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

February 7, 2013

Last Update Submit

July 23, 2015

Conditions

Tracheotomy

Keywords

TracheotomyWeaning from mechanical ventilationLung ultrasound score

Outcome Measures

Primary Outcomes (1)

  • Variation of lung ultrasound score

    at day 1

Secondary Outcomes (2)

  • Time to weaning from mechanical ventilation

    at day 1

  • Length of hospital stay

    Day 1 + 90 days

Study Arms (1)

tracheotomized patients

EXPERIMENTAL
Procedure: Tracheotomy

Interventions

TracheotomyPROCEDURE
tracheotomized patients

Eligibility Criteria

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

You may qualify if:

  • Adult patients tracheotomised during ICU stay
  • Consent of patients

You may not qualify if:

  • Tracheotomy before ICU
  • No echogenicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Tracheotomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 15, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

FR(1)