Back to resultsEfficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Tracheostomy on day 3-5 in early group and 10-12 in late group
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Sites / Locations
- University of Turin, Department of Anesthesia and Intensive Care Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early (A)
Late (B)
Arm Description
Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.
Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.
Outcomes
Primary Outcome Measures
Increase of "ventilator associated pneumonia-free days"
Secondary Outcome Measures
Increase of "ventilator-free days"
Reduction of mortality
Full Information
NCT ID
NCT00262431
First Posted
December 5, 2005
Last Updated
June 7, 2012
Sponsor
University of Turin, Italy
Collaborators
Regione Piemonte
1. Study Identification
Unique Protocol Identification Number
NCT00262431
Brief Title
Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
Collaborators
Regione Piemonte
4. Oversight
5. Study Description
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.
Detailed Description
Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical ventilation and hence shorter Intensive Care Unit (ICU) length of stay, as well as better resource rationalization. Actually there is no agreement on the best timing for tracheostomy. The aim of this study is to verify if an early tracheostomy (one to three days after intubation) increases ventilator associated pneumonia-free days. Secondary endpoints are: increase of ventilator free-days and mortality reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early (A)
Arm Type
Active Comparator
Arm Description
Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation.
Arm Title
Late (B)
Arm Type
Active Comparator
Arm Description
Patients of the LATE group (B) will undergo tracheostomy on day 10-12 from oro/nasotracheal intubation.
Intervention Type
Procedure
Intervention Name(s)
Tracheostomy on day 3-5 in early group and 10-12 in late group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase of "ventilator associated pneumonia-free days"
Time Frame
Follow-up terminates on day 28 from the date of oro/nasotracheal intubation.
Secondary Outcome Measure Information:
Title
Increase of "ventilator-free days"
Time Frame
Follow-up terminates on day 28 from the date of oro/nasotracheal intubation
Title
Reduction of mortality
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. M. Ranieri, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
V. M. Ranieri, MD
Organizational Affiliation
University of Turin, Italy
Official's Role
Study Director
Facility Information:
Facility Name
University of Turin, Department of Anesthesia and Intensive Care Medicine
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
20407057
Citation
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.
Results Reference
derived
Links:
URL
https://elt.ddmc.unito.it/eltdoc
Description
Related Info
Learn more about this trial
Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
We'll reach out to this number within 24 hrs