Respiratory InsufficiencyPhase 3NCT00127621
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
A Phase 3 study testing early tracheotomy and prolonged endotracheal intubation in people with Respiratory Insufficiency, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- early tracheotomy and prolonged endotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 468 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2002to Apr 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under ventilation support for at least 4 days
- Patients needing ventilatory support for > 7 days
- Age > 18 years
- Informed consent signed
Who cannot join
- Patients previously tracheotomised
- Major hemorrhagic risk
- Patients previously randomised in a trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.
- Conditions
- Respiratory Insufficiency
- Being tested
- early tracheotomy, prolonged endotracheal intubation
- Keywords
- ICU patients needing prolonged ventilatory support
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early tracheotomyProcedure or surgery
prolonged endotracheal intubationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
amount of sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startApr 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- François BLOT, Dr, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127621
- Sponsor's protocol ID
- TRACHEO
- Status last verified
- Aug 2005
- First submitted
- 5 Aug 2005
- Last updated
- 25 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT00127621
- Acronym / sponsor ID
- TRACHEO
- Conditions
- Respiratory Insufficiency
- Keywords
- ICU patients needing prolonged ventilatory support
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 468 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Apr 2005
- First posted
- 8 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients under ventilation support for at least 4 days
- Patients needing ventilatory support for > 7 days
- Age > 18 years
- Informed consent signed
Key exclusion criteria (3 listed)
- Patients previously tracheotomised
- Major hemorrhagic risk
- Patients previously randomised in a trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early tracheotomy | Procedure or surgery | – |
| prolonged endotracheal intubation | Procedure or surgery | – |
Primary outcome
28 days mortality
cumulated incidence of nosocomial pneumonia between days 1 and 28
number of ventilatory free days between days 1 and 28
6 secondary outcomes
time in the ICU
time on mechanical ventilation
60 days mortality
number of septic episodes
accidental extubation
amount of sedation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François BLOT, Dr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing early tracheotomy and prolonged endotracheal intubation in people with Respiratory Insufficiency, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days mortality. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2005.