TracheotomyTRAWELUSNCT01793363
Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score
A study testing Tracheotomy in people with Tracheotomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheotomy
- What is being tested?
- Tracheotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Nov 2014
- Phase
- Interventional
- 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
- Adult patients tracheotomised during ICU stay
- Consent of patients
Who cannot join
- Tracheotomy before ICU
- No echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients
Read the detailed description
Prospective multicentric study on ICU evaluating Lung Ultrasound Score in tracheotomized patients during weaning from mechanical ventilation
- Conditions
- Tracheotomy
- Being tested
- Tracheotomy
- Keywords
- Tracheotomy, Weaning from mechanical ventilation, Lung ultrasound score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| tracheotomized patients | Experimental | Not described Receives: Procedure: Tracheotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of lung ultrasound score
Measured: at day 1
Secondary outcomes (2)
Time to weaning from mechanical ventilation
Measured: at day 1
Length of hospital stay
Measured: Day 1 + 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheotomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793363
- Sponsor's protocol ID
- CHU-0144
- Other IDs
- 2012-A00366-37
- Acronym
- TRAWELUS
- Status last verified
- Jul 2015
- First submitted
- 7 Feb 2013
- Last updated
- 24 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score
- ClinicalTrials.gov ID
- NCT01793363
- Acronym / sponsor ID
- TRAWELUS / CHU-0144
- Conditions
- Tracheotomy
- Keywords
- Tracheotomy, Weaning from mechanical ventilation, Lung ultrasound score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 Feb 2013 (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.
Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients
Detailed description
Prospective multicentric study on ICU evaluating Lung Ultrasound Score in tracheotomized patients during weaning from mechanical ventilation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tracheotomized patients | Experimental | Procedure: Tracheotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients tracheotomised during ICU stay
- Consent of patients
Key exclusion criteria (2 listed)
- Tracheotomy before ICU
- No echogenicity
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 |
|---|---|---|
| Tracheotomy | Procedure or surgery | tracheotomized patients |
Primary outcome
Variation of lung ultrasound score
Time frame: at day 1
2 secondary outcomes
Time to weaning from mechanical ventilation
Time frame: at day 1
Length of hospital stay
Time frame: Day 1 + 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheotomy in people with Tracheotomy, run by University Hospital, Clermont-Ferrand 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jul 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation of lung ultrasound score (time frame: at day 1). 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 24 Jul 2015.