Status:
COMPLETED
Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Respiratory Failure
Cardiovascular Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
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 studie...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00347321
Start Date
July 1 2006
End Date
June 1 2009
Last Update
December 3 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp
Paris, France, 75013