COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC) (ETOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347321
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : December 3, 2009
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Cardiovascular Surgery Procedure: Dilatational Percutaneous tracheostomy Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy
Procedure: Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy

Primary Outcome Measures :
  1. 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. ]
  2. VFDs = 0 if the patient dies before 60days. [ Time Frame: before 60 days ]
  3. 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 ]
  4. VFDs = 0: if the patient requires MV for 60 days or more [ Time Frame: during 60 days and after ]
  5. The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean) [ Time Frame: at 7 days ]

Secondary Outcome Measures :
  1. Other outcomes will be compared between the two arms: [ Time Frame: during the trial ]
  2. Mortality rate (day 60, in-ICU, in-hospital) [ Time Frame: during the 60 days ]
  3. ICU length of stay [ Time Frame: during the trial ]
  4. Hospital length of stay [ Time Frame: during the trial ]
  5. Duration of MV in survivors [ Time Frame: during the trial ]
  6. Organ failure evolution [ Time Frame: during the trial ]
  7. Infectious complications [ Time Frame: during the trial ]
  8. Early laryngeal and tracheal complications [ Time Frame: during the trial ]
  9. Sedation needs [ Time Frame: during the trial ]
  10. Patient comfort [ Time Frame: during the trial ]
  11. Outcome on day 90 [ Time Frame: to 90 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347321

Layout table for location information
Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Layout table for investigator information
Principal Investigator: Jean Louis TROUILLET, MD, Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christophe AUCAN, Department Clinical Research of Developpement Identifier: NCT00347321    
Other Study ID Numbers: P051013
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: December 3, 2009
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Percutaneous tracheostomy
Endotracheal intubation
Mechanical ventilation
Cardiac surgery
Ventilator-free days
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases