- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01546974
Ventilator-associated Pneumonia (VAP) and Humidification System
March 6, 2012 updated by: José Raimundo Araujo de Azevedo, Hospital Sao Domingos
Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
306
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jose R Azevedo, MD
- Phone Number: 55 98 32168110
- Email: jrazevedo@elo.com.br
Study Locations
-
-
MA
-
Sao Luis, MA, Brazil, 65060-000
- Recruiting
- Hospital São Domingos
-
Principal Investigator:
- Jose R Azevedo, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients expected to require mechanical ventilation for at least 48 hours
Exclusion Criteria:
- Patients < 18 yo and pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HME filter
|
|
Experimental: Heated humidificator MR 730 Fisher & Paykel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
VAP incidence
|
Secondary Outcome Measures
Outcome Measure |
---|
Duration of mechanical ventilation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: JOSE R AZEVEDO, MD, DIRECTOR ICU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
February 1, 2014
Study Registration Dates
First Submitted
March 3, 2012
First Submitted That Met QC Criteria
March 6, 2012
First Posted (Estimate)
March 7, 2012
Study Record Updates
Last Update Posted (Estimate)
March 7, 2012
Last Update Submitted That Met QC Criteria
March 6, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hsd2012
- CEP026/2011 (Other Identifier: Hospital Sao Domingos)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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