Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC)

NCT ID: NCT00347321

Last Updated: 2009-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-06-30

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.

Conditions

Respiratory Failure; Cardiovascular Surgery

Keywords

Percutaneous tracheostomy; Endotracheal intubation; Mechanical ventilation; Cardiac surgery; Ventilator-free days

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dilatational Percutaneous tracheostomy

Dilatational Percutaneous tracheostomy

Group Type: EXPERIMENTAL

Dilatational Percutaneous tracheostomy

Intervention Type: PROCEDURE

Dilatational Percutaneous tracheostomy

Interventions

Dilatational Percutaneous tracheostomy

Dilatational Percutaneous tracheostomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpement

Principal Investigators

Jean Louis TROUILLET, MD,

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 21403073 (View on PubMed)

Other Identifiers

P051013

Identifier Type: -

Identifier Source: org_study_id