NCT00127621

Brief Summary

This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
468

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
Last Updated

August 25, 2005

Status Verified

August 1, 2005

First QC Date

August 5, 2005

Last Update Submit

August 24, 2005

Conditions

Respiratory Insufficiency

Keywords

ICU patients needing prolonged ventilatory support

Outcome Measures

Primary Outcomes (3)

  • 28 days mortality

  • cumulated incidence of nosocomial pneumonia between days 1 and 28

  • number of ventilatory free days between days 1 and 28

Secondary Outcomes (6)

  • time in the ICU

  • time on mechanical ventilation

  • 60 days mortality

  • number of septic episodes

  • accidental extubation

  • +1 more secondary outcomes

Interventions

early tracheotomyPROCEDURE
prolonged endotracheal intubationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Patients under ventilation support for at least 4 days
  • Patients needing ventilatory support for \> 7 days
  • Age \> 18 years
  • Informed consent signed

You may not qualify if:

  • Patients previously tracheotomised
  • Major hemorrhagic risk
  • Patients previously randomised in a trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • François BLOT, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 8, 2005

Study Start

April 1, 2002

Study Completion

April 1, 2005

Last Updated

August 25, 2005

Record last verified: 2005-08

Locations

FR(1)