Back to resultsEarly Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
Primary Purpose
Respiratory Insufficiency
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
early tracheotomy
prolonged endotracheal intubation
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring ICU patients needing prolonged ventilatory support
Eligibility Criteria
Inclusion Criteria: Patients under ventilation support for at least 4 days Patients needing ventilatory support for > 7 days Age > 18 years Informed consent signed Exclusion Criteria: Patients previously tracheotomised Major hemorrhagic risk Patients previously randomised in a trial
Sites / Locations
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
28 days mortality
cumulated incidence of nosocomial pneumonia between days 1 and 28
number of ventilatory free days between days 1 and 28
Secondary Outcome Measures
time in the ICU
time on mechanical ventilation
60 days mortality
number of septic episodes
accidental extubation
amount of sedation
Full Information
NCT ID
NCT00127621
First Posted
August 5, 2005
Last Updated
August 24, 2005
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00127621
Brief Title
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
Official Title
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Terminated
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
Brief Summary
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
ICU patients needing prolonged ventilatory support
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
468 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
early tracheotomy
Intervention Type
Procedure
Intervention Name(s)
prolonged endotracheal intubation
Primary Outcome Measure Information:
Title
28 days mortality
Title
cumulated incidence of nosocomial pneumonia between days 1 and 28
Title
number of ventilatory free days between days 1 and 28
Secondary Outcome Measure Information:
Title
time in the ICU
Title
time on mechanical ventilation
Title
60 days mortality
Title
number of septic episodes
Title
accidental extubation
Title
amount of sedation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients under ventilation support for at least 4 days
Patients needing ventilatory support for > 7 days
Age > 18 years
Informed consent signed
Exclusion Criteria:
Patients previously tracheotomised
Major hemorrhagic risk
Patients previously randomised in a trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François BLOT, Dr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
Learn more about this trial
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
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