Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC) (ETOC)
|Respiratory Failure Cardiovascular Surgery||Procedure: Dilatational Percutaneous tracheostomy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation|
- 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 ]
- 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 ]
|Study Start Date:||July 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy
Procedure: Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347321
|Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp|
|Paris, France, 75013|
|Principal Investigator:||Jean Louis TROUILLET, MD,||Assistance Publique - Hôpitaux de Paris|