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Ventilator-associated Pneumonia (VAP) and Humidification System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by José Raimundo Araujo de Azevedo, Hospital Sao Domingos.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos Identifier:
First received: March 3, 2012
Last updated: March 6, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Ventilator-associated Pneumonia
Device: HME filter Twin Star 55, Drager Medical, Germany
Device: Heated humidification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification

Resource links provided by NLM:

Further study details as provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:

Primary Outcome Measures:
  • VAP incidence

Secondary Outcome Measures:
  • Duration of mechanical ventilation

Estimated Enrollment: 306
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HME filter Device: HME filter Twin Star 55, Drager Medical, Germany
Experimental: Heated humidificator MR 730 Fisher & Paykel Device: Heated humidification


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients expected to require mechanical ventilation for at least 48 hours

Exclusion Criteria:

  • Patients < 18 yo and pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT01546974

Contact: JOSE R AZEVEDO, MD 55 98 32168110

Hospital Sao Domingos Recruiting
Sao Luis, MA, Brazil, 65060-000
Principal Investigator: JOSE R AZEVEDO, MD         
Sponsors and Collaborators
Hospital Sao Domingos
Study Chair: JOSE R AZEVEDO, MD Director ICU
  More Information

Responsible Party: José Raimundo Araujo de Azevedo, Coordinator ICU, Hospital Sao Domingos Identifier: NCT01546974     History of Changes
Other Study ID Numbers: hsd2012
CEP026/2011 ( Other Identifier: Hospital Sao Domingos )
Study First Received: March 3, 2012
Last Updated: March 6, 2012

Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
Mechanical Ventilation
Humidification system
Patients submitted to mechanical ventilation for at least 48 hours

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury processed this record on May 25, 2017