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Ventilator-associated Pneumonia (VAP) and Humidification System

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ClinicalTrials.gov Identifier: NCT01546974
Recruitment Status : Unknown
Verified January 2012 by José Raimundo Araujo de Azevedo, Hospital Sao Domingos.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HME filter Device: HME filter Twin Star 55, Drager Medical, Germany
Experimental: Heated humidificator MR 730 Fisher & Paykel Device: Heated humidification


Outcome Measures

Primary Outcome Measures :
  1. VAP incidence

Secondary Outcome Measures :
  1. Duration of mechanical ventilation

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients < 18 yo and pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546974


Contacts
Contact: JOSE R AZEVEDO, MD 55 98 32168110 jrazevedo@elo.com.br

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

Responsible Party: José Raimundo Araujo de Azevedo, Coordinator ICU, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT01546974     History of Changes
Other Study ID Numbers: hsd2012
CEP026/2011 ( Other Identifier: Hospital Sao Domingos )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: January 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
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury