Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00127621
• Collaborator: (none)
• Enrollment: 468
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 13

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Insufficiency	Procedure: early tracheotomy; Procedure: prolonged endotracheal intubation	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients
• Study Start Date: Apr 1, 2002
• Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

1. 28 days mortality []

2. cumulated incidence of nosocomial pneumonia between days 1 and 28 []

3. number of ventilatory free days between days 1 and 28 []

Secondary Outcome Measures

1. time in the ICU []

2. time on mechanical ventilation []

3. 60 days mortality []

4. number of septic episodes []

5. accidental extubation []

6. amount of sedation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

• Principal Investigator: François BLOT, Dr, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00127621
• Other Study ID Numbers: TRACHEO
• First Posted: Aug 8, 2005
• Last Update Posted: Aug 25, 2005
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: ICU patients needing prolonged ventilatory support
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Aug 25, 2005