Early Percutaneous Tracheostomy for Cardiac Surgery (ETOC)

Respiratory Failure Clinical Trial

— ETOC  

Official title:

Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347321
• Other study ID #: P051013
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2006
• Last updated: December 2, 2009
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Surgery
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Dilatational Percutaneous tracheostomy
Dilatational Percutaneous tracheostomy

Locations

Country	Name	City	State
France	Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment.		between successful weaning from MV and day 60 after study enrolment.	Yes
Primary	VFDs = 0 if the patient dies before 60days.		before 60 days	Yes
Primary	VFDs= (60- X) : if the patient is successfully weaned from MV within 60 days, where X is the number of days spent receiving MV		during 60 days	Yes
Primary	VFDs = 0: if the patient requires MV for 60 days or more		during 60 days and after	Yes
Primary	The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean)		at 7 days	Yes
Secondary	Other outcomes will be compared between the two arms:		during the trial	Yes
Secondary	Mortality rate (day 60, in-ICU, in-hospital)		during the 60 days	Yes
Secondary	ICU length of stay		during the trial	Yes
Secondary	Hospital length of stay		during the trial	Yes
Secondary	Duration of MV in survivors		during the trial	Yes
Secondary	Organ failure evolution		during the trial	Yes
Secondary	Infectious complications		during the trial	Yes
Secondary	Early laryngeal and tracheal complications		during the trial	Yes
Secondary	Sedation needs		during the trial	Yes
Secondary	Patient comfort		during the trial	Yes
Secondary	Outcome on day 90		to 90 days	Yes