Clinical trial NCT00347321: Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC)
Official title: Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Cardiovascular Surgery
Keywords: Percutaneous tracheostomy
Endotracheal intubation
Mechanical ventilation
Cardiac surgery
Ventilator-free days
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-07-04
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment.
timeFrame: between successful weaning from MV and day 60 after study enrolment.
measure: VFDs = 0 if the patient dies before 60days.
timeFrame: before 60 days
measure: VFDs= (60- X) : if the patient is successfully weaned from MV within 60 days, where X is the number of days spent receiving MV
timeFrame: during 60 days
measure: VFDs = 0: if the patient requires MV for 60 days or more
timeFrame: during 60 days and after
measure: The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean)
timeFrame: at 7 days
Secondary outcomes:
measure: Other outcomes will be compared between the two arms:
timeFrame: during the trial
measure: Mortality rate (day 60, in-ICU, in-hospital)
timeFrame: during the 60 days
measure: ICU length of stay
timeFrame: during the trial
measure: Hospital length of stay
timeFrame: during the trial
measure: Duration of MV in survivors
timeFrame: during the trial
measure: Organ failure evolution
timeFrame: during the trial
measure: Infectious complications
timeFrame: during the trial
measure: Early laryngeal and tracheal complications
timeFrame: during the trial
measure: Sedation needs
timeFrame: during the trial
measure: Patient comfort
timeFrame: during the trial
measure: Outcome on day 90
timeFrame: to 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Louis TROUILLET, MD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.