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

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

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.

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

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.

Clinical Trials on Ventilator-associated Pneumonia

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