Respiratory FailurePhase 3ETOCNCT00347321
Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC)
A Phase 3 study testing Dilatational Percutaneous tracheostomy in people with Respiratory Failure and Cardiovascular Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a phase III clinical trial comparing early tracheostomy (day 4) versus prolonged endotracheal intubation in ICU patients needing prolonged ventilatory support after cardiovascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Cardiovascular Surgery
- What is being tested?
- Dilatational Percutaneous tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to Jun 2009
- 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
- Are 18 years of age or older
- Have undergone cardiovascular surgery
- Are still on invasive mechanical ventilation on day 4 after surgery
- Have failed the screening test or the spontaneous breathing trial
- Have signed the informed consent (patient or legal representative)
Who cannot join
- Age less than18
- Pregnant woman
- Intubation more than 48 hours before cardiovascular surgery
- More than 5 days on mechanical ventilation after cardiac surgery
- Artificial heart implantation
- Concomitant neck surgery (carotid)
Show all 18Show fewer
- Previously tracheostomized
- Major hemorrhagic risk
- Persistence of platelet count less than 50.000/mm3 after platelet transfusion
- Prothrombin time less than 30% despite coagulation factors administration
- Clinical evidence of ongoing infection at the proposed tracheotomy site
- Anatomical deformity of the neck making risky a tracheostomy
- Probability of dying the day of randomization defined by SAPSII more than 80
- Irreversible neurological lesions
- Decision of care limitation
- Prior inclusion in a trial with morbidity-mortality as main judgement criteria
- Previous enrollment in this trial
- Consent refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp
Paris, 75013
About this study
Official title: Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation
This is a phase III clinical trial comparing early tracheostomy (day 4) versus prolonged endotracheal intubation in ICU patients needing prolonged ventilatory support after cardiovascular surgery.
Read the detailed description
Background: Prolonged mechanical ventilation (MV> 7 days) is required in less than 10% of patients after cardiovascular surgery but it is associated with high morbidity and mortality.
Several studies conducted in critically ill patients suggested that early percutaneous tracheotomy compared with delayed tracheotomy decreases the length of ventilator dependence and improves outcome. To date, no randomized trial has tested these possible benefits in critically ill patients after cardiac surgery.
Study objectives: A randomized trial has been designed to determine whether early tracheostomy (day 4 after cardiac surgery) in patients still on MV would reduce the number of days under MV, measured by the evaluation of ventilator-free days (VFDs). Secondary objectives are the reduction of mortality, reduction of ICU and hospital length of stay. Evaluation of organ failure evolution, infectious complications, sedation needs, patient comfort and outcome at 3 months will be also considered.
Study hypothesis: The trial will be consider positive if early tracheotomy increases the number VFDs of at least 7 days (mean) evaluated on day 60 after randomisation.
Methods :
Trial : randomized, open, controlled, monocentric Inclusion criteria: see columns below Exclusion criteria: see columns below Randomization: will use a computerised system on day 4 after cardiac surgery Procedures: see columns below Recorded data: demographic characteristics, pre, per and postoperative parameters.
From randomization until ICU discharge (or day 60), a daily chart will be completed.
Judgment criteria: see columns below Sample size and statistical analysis: using Wilcoxon bilateral test with an alpha risk of 5% and a power of 80%, we calculated that 108 patients in each arm would be needed.
Statistical analyses will use standard tests to compare population of the two arms.
- Conditions
- Respiratory Failure, Cardiovascular Surgery
- Being tested
- Dilatational Percutaneous tracheostomy
- Keywords
- Percutaneous tracheostomy, Endotracheal intubation, Mechanical ventilation, Cardiac surgery, Ventilator-free days
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilatational Percutaneous tracheostomyProcedure or surgery
Dilatational Percutaneous tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Dilatational Percutaneous tracheostomy | Experimental | Dilatational Percutaneous tracheostomy Receives: Procedure: Dilatational Percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment.
Measured: between successful weaning from MV and day 60 after study enrolment.
VFDs = 0 if the patient dies before 60days.
Measured: before 60 days
VFDs= (60- X) : if the patient is successfully weaned from MV within 60 days, where X is the number of days spent receiving MV
Measured: during 60 days
VFDs = 0: if the patient requires MV for 60 days or more
Measured: during 60 days and after
The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean)
Measured: at 7 days
Secondary outcomes (11)
Other outcomes will be compared between the two arms:
Measured: during the trial
Mortality rate (day 60, in-ICU, in-hospital)
Measured: during the 60 days
ICU length of stay
Measured: during the trial
Hospital length of stay
Measured: during the trial
Duration of MV in survivors
Measured: during the trial
Organ failure evolution
Measured: during the trial
Infectious complications
Measured: during the trial
Early laryngeal and tracheal complications
Measured: during the trial
Sedation needs
Measured: during the trial
Patient comfort
Measured: during the trial
Outcome on day 90
Measured: to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de 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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Jean Louis TROUILLET, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347321
- Sponsor's protocol ID
- P051013
- Acronym
- ETOC
- Status last verified
- Mar 2007
- First submitted
- 29 Jun 2006
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trouillet JL, Luyt CE, Guiguet M, Ouattara A, Vaissier E, Makri R, Nieszkowska A, Leprince P, Pavie A, Chastre J, Combes A. Early percutaneous tracheotomy versus prolonged intubation of mechanically ventilated patients after cardiac surgery: a randomized trial. Ann Intern Med. 2011 Mar 15;154(6):373-83. doi: 10.7326/0003-4819-154-6-201103150-00002.
PubMed 21403073
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00347321
- Acronym / sponsor ID
- ETOC / P051013
- Conditions
- Respiratory Failure, Cardiovascular Surgery
- Keywords
- Percutaneous tracheostomy, Endotracheal intubation, Mechanical ventilation, Cardiac surgery, Ventilator-free days
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jul 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Jul 2006 (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 clinical trial comparing early tracheostomy (day 4) versus prolonged endotracheal intubation in ICU patients needing prolonged ventilatory support after cardiovascular surgery.
Detailed description
Background: Prolonged mechanical ventilation (MV> 7 days) is required in less than 10% of patients after cardiovascular surgery but it is associated with high morbidity and mortality.
Several studies conducted in critically ill patients suggested that early percutaneous tracheotomy compared with delayed tracheotomy decreases the length of ventilator dependence and improves outcome. To date, no randomized trial has tested these possible benefits in critically ill patients after cardiac surgery.
Study objectives: A randomized trial has been designed to determine whether early tracheostomy (day 4 after cardiac surgery) in patients still on MV would reduce the number of days under MV, measured by the evaluation of ventilator-free days (VFDs). Secondary objectives are the reduction of mortality, reduction of ICU and hospital length of stay. Evaluation of organ failure evolution, infectious complications, sedation needs, patient comfort and outcome at 3 months will be also considered.
Study hypothesis: The trial will be consider positive if early tracheotomy increases the number VFDs of at least 7 days (mean) evaluated on day 60 after randomisation.
Methods :
Trial : randomized, open, controlled, monocentric Inclusion criteria: see columns below Exclusion criteria: see columns below Randomization: will use a computerised system on day 4 after cardiac surgery Procedures: see columns below Recorded data: demographic characteristics, pre, per and postoperative parameters.
From randomization until ICU discharge (or day 60), a daily chart will be completed.
Judgment criteria: see columns below Sample size and statistical analysis: using Wilcoxon bilateral test with an alpha risk of 5% and a power of 80%, we calculated that 108 patients in each arm would be needed.
Statistical analyses will use standard tests to compare population of the two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dilatational Percutaneous tracheostomy | Experimental | Procedure: Dilatational Percutaneous tracheostomyDilatational Percutaneous tracheostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are 18 years of age or older
- Have undergone cardiovascular surgery
- Are still on invasive mechanical ventilation on day 4 after surgery
- Have failed the screening test or the spontaneous breathing trial
- Have signed the informed consent (patient or legal representative)
Key exclusion criteria (18 listed)
- Age less than18
- Pregnant woman
- Intubation more than 48 hours before cardiovascular surgery
- More than 5 days on mechanical ventilation after cardiac surgery
- Artificial heart implantation
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 |
|---|---|---|
| Dilatational Percutaneous tracheostomyDilatational Percutaneous tracheostomy | Procedure or surgery | Dilatational Percutaneous tracheostomy |
Primary outcome
Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment.
Time frame: between successful weaning from MV and day 60 after study enrolment.
VFDs = 0 if the patient dies before 60days.
Time frame: before 60 days
VFDs= (60- X) : if the patient is successfully weaned from MV within 60 days, where X is the number of days spent receiving MV
Time frame: during 60 days
VFDs = 0: if the patient requires MV for 60 days or more
Time frame: during 60 days and after
The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean)
Time frame: at 7 days
11 secondary outcomes
Other outcomes will be compared between the two arms:
Time frame: during the trial
Mortality rate (day 60, in-ICU, in-hospital)
Time frame: during the 60 days
ICU length of stay
Time frame: during the trial
Hospital length of stay
Time frame: during the trial
Duration of MV in survivors
Time frame: during the trial
Organ failure evolution
Time frame: during the trial
Infectious complications
Time frame: during the trial
Early laryngeal and tracheal complications
Time frame: during the trial
Sedation needs
Time frame: during the trial
Patient comfort
Time frame: during the trial
Outcome on day 90
Time frame: to 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 3 Dec 2009.
- Derived from this study: PubMed 21403073Trouillet JL, Luyt CE, Guiguet M, Ouattara A, Vaissier E, Makri R, Nieszkowska A, Leprince P, Pavie A, Chastre J, Combes A. Early percutaneous tracheotomy versus prolonged intubation of mechanically ventilated patients after cardiac surgery: a randomized trial. Ann Intern Med. 2011 Mar 15;154(6):373-83. doi: 10.7326/0003-4819-154-6-201103150-00002.
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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.
Jean Louis TROUILLET, MD, principal investigator
Assistance Publique - Hôpitaux de 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 Dilatational Percutaneous tracheostomy in people with Respiratory Failure and Cardiovascular Surgery, run by Assistance Publique - Hôpitaux de 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 5 inclusion and 18 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 3 Dec 2009. 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 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?
Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment. (time frame: between successful weaning from MV and day 60 after study enrolment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00347321, which also lists 1 linked publication.
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 3 Dec 2009.