Ventilator-associated Pneumonia (VAP) and Humidification System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hospital Sao Domingos.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos
ClinicalTrials.gov Identifier:
NCT01546974
First received: March 3, 2012
Last updated: March 6, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 Hospital Sao Domingos:

Primary Outcome Measures:
  • VAP incidence [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of mechanical ventilation [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 3, 2012
Last Updated: March 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014