NCT00262431

Brief Summary

The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2004

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

Study Start

First participant enrolled

June 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

4 years

First QC Date

December 5, 2005

Last Update Submit

June 7, 2012

Conditions

Respiratory Insufficiency

Keywords

TracheostomyTracheostomy timingVentilator associated pneumoniaMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Increase of "ventilator associated pneumonia-free days"

    Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.

Secondary Outcomes (2)

  • Increase of "ventilator-free days"

    Follow-up terminates on day 28 from the date of oro/nasotracheal intubation

  • Reduction of mortality

    one year

Study Arms (2)

Early (A)

ACTIVE COMPARATOR

Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.

Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group

Late (B)

ACTIVE COMPARATOR

Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.

Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group

Interventions

Tracheostomy on day 3-5 in early group and 10-12 in late groupPROCEDURE

Upon admission to ICU, acute respiratory failure patients requiring at least 3 days of mechanical ventilation and defined by a SAPS II score between 35 and 65, will be randomly assigned to either arm A or B of the study.

Early (A)Late (B)

Eligibility Criteria

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

You may qualify if:

  • Oro/nasotracheal intubation for less than three days
  • Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)

You may not qualify if:

  • Oro/nasotracheal intubation \> three days
  • Age \< 18 years
  • Previous otolaryngologic or maxillofacial procedures
  • Brain injury patients with intracranial pressure \> 20 mmHg without pharmacological treatment (or intracranial pressure \> 15 mmHg under specific pharmacological treatment) and with cerebral perfusion pressure \< 60 mmHg
  • Pregnancy
  • Ventilator associated pneumonia, hospital acquired pneumonia, community acquired pneumonia diagnosis before randomization
  • Infection in the tracheostomic area
  • Acute worsening of chronic obstructive pulmonary disease (COPD)
  • Pre-existing malignancies in the tracheostomic area
  • Immunosuppressed and/or immunodepressed patients:
  • leukocytes \< 1000/microliters
  • neutrophils \< 500/microliters
  • AIDS
  • long-term steroid treatment (daily dose \> 0.5 mg/kg for more than 30 days)
  • Patients already enrolled in other trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, 10126, Italy

Location

Related Publications (1)

  • Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9. doi: 10.1001/jama.2010.447.

    PMID: 20407057DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesHealthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • V. M. Ranieri, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • V. M. Ranieri, MD

    University of Turin, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 5, 2005

First Posted

December 6, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

IT(1)