Back to resultsVentilator-associated Pneumonia (VAP) and Humidification System
Primary Purpose
Ventilator-associated Pneumonia
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
HME filter Twin Star 55, Drager Medical, Germany
Heated humidification
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-associated Pneumonia focused on measuring Mechanical Ventilation, Humidification system, Patients submitted to mechanical ventilation for at least 48 hours
Eligibility Criteria
Inclusion Criteria:
- Patients expected to require mechanical ventilation for at least 48 hours
Exclusion Criteria:
- Patients < 18 yo and pregnant
Sites / Locations
- Hospital Sao DomingosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HME filter
Heated humidificator MR 730 Fisher & Paykel
Arm Description
Outcomes
Primary Outcome Measures
VAP incidence
Secondary Outcome Measures
Duration of mechanical ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01546974
Brief Title
Ventilator-associated Pneumonia (VAP) and Humidification System
Official Title
Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sao Domingos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which humidification system is more effective in preventing pneumonia in mechanically ventilated patients. The study will compare a heat and moisture exchanger versus heated humidification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
Mechanical Ventilation, Humidification system, Patients submitted to mechanical ventilation for at least 48 hours
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HME filter
Arm Type
Experimental
Arm Title
Heated humidificator MR 730 Fisher & Paykel
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HME filter Twin Star 55, Drager Medical, Germany
Intervention Type
Device
Intervention Name(s)
Heated humidification
Primary Outcome Measure Information:
Title
VAP incidence
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients expected to require mechanical ventilation for at least 48 hours
Exclusion Criteria:
Patients < 18 yo and pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JOSE R AZEVEDO, MD
Phone
55 98 32168110
Email
jrazevedo@elo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSE R AZEVEDO, MD
Organizational Affiliation
Director ICU
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Sao Domingos
City
Sao Luis
State/Province
MA
ZIP/Postal Code
65060-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSE R AZEVEDO, MD
12. IPD Sharing Statement
Learn more about this trial
Ventilator-associated Pneumonia (VAP) and Humidification System
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