Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC)

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00347321
First received: June 29, 2006
Last updated: December 2, 2009
Last verified: March 2007
  Purpose

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 Intervention Phase
Respiratory Failure
Cardiovascular Surgery
Procedure: Dilatational Percutaneous tracheostomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • Other outcomes will be compared between the two arms: [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Mortality rate (day 60, in-ICU, in-hospital) [ Time Frame: during the 60 days ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Hospital length of stay [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Duration of MV in survivors [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Organ failure evolution [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Infectious complications [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Early laryngeal and tracheal complications [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Sedation needs [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Patient comfort [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]
  • Outcome on day 90 [ Time Frame: to 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 212
Study Start Date: July 2006
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy
Procedure: Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy
Other Name: Dilatational Percutaneous tracheostomy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347321

Locations
France
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
Investigators
Principal Investigator: Jean Louis TROUILLET, MD, Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe AUCAN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00347321     History of Changes
Other Study ID Numbers: P051013
Study First Received: June 29, 2006
Last Updated: December 2, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Percutaneous tracheostomy
Endotracheal intubation
Mechanical ventilation
Cardiac surgery
Ventilator-free days

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014