NCT00347321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 3, 2009

Status Verified

March 1, 2007

Enrollment Period

2.7 years

First QC Date

June 29, 2006

Last Update Submit

December 2, 2009

Conditions

Respiratory FailureCardiovascular Surgery

Keywords

Percutaneous tracheostomyEndotracheal intubationMechanical ventilationCardiac surgeryVentilator-free days

Outcome Measures

Primary Outcomes (5)

  • 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.

  • VFDs = 0 if the patient dies before 60days.

    before 60 days

  • 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

  • VFDs = 0: if the patient requires MV for 60 days or more

    during 60 days and after

  • The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean)

    at 7 days

Secondary Outcomes (11)

  • Other outcomes will be compared between the two arms:

    during the trial

  • Mortality rate (day 60, in-ICU, in-hospital)

    during the 60 days

  • ICU length of stay

    during the trial

  • Hospital length of stay

    during the trial

  • Duration of MV in survivors

    during the trial

  • +6 more secondary outcomes

Study Arms (1)

Dilatational Percutaneous tracheostomy

EXPERIMENTAL

Dilatational Percutaneous tracheostomy

Procedure: Dilatational Percutaneous tracheostomy

Interventions

Dilatational Percutaneous tracheostomyPROCEDURE

Dilatational Percutaneous tracheostomy

Dilatational Percutaneous tracheostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cardiologie - Chu Pitie Salpetriere Ap-Hp

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 21403073DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jean Louis TROUILLET, MD,

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

December 3, 2009

Record last verified: 2007-03

Locations

FR(1)