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NCT01546974 Clinical Trial

Ventilator-associated Pneumonia (VAP) and Humidification System

Ventilator-associated Pneumonia Clinical Trial

Official title:
Prospective Analysis of the Incidence of Ventilator-associated Pneumonia Related to the Humidification System: Heat and Moisture Exchanger Versus Heated Humidification

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01546974
Other study ID # hsd2012
Secondary ID CEP026/2011
Status Recruiting
Phase Phase 4
First received March 3, 2012
Last updated March 6, 2012
Start date November 2011
Est. completion date February 2014

Study information
Verified date January 2012
Source Hospital Sao Domingos
Contact JOSE R AZEVEDO, MD
Phone 55 98 32168110
Email jrazevedo@elo.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 306
Est. completion date February 2014
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patients < 18 yo and pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• HME filter Twin Star 55, Drager Medical, Germany

• Heated humidification

Locations
Country Name City State
Brazil Hospital Sao Domingos Sao Luis MA

Sponsors (1)
Lead Sponsor Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAP incidence Yes
Secondary Duration of mechanical ventilation No
See also
  Status Clinical Trial Phase
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Recruiting NCT03581370 - Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients With Ventilator Associated-pneumonia Phase 3
Completed NCT02070757 - Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) Phase 3
Completed NCT03348579 - Hospital-acquired Pneumonia in Intensive Care Unit
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Completed NCT02838160 - Effectiveness of Different Educational Strategies on the KAP, Psychological and Clinical Outcomes N/A
Completed NCT01467648 - The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia Phase 4
Completed NCT00364299 - Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure N/A
Not yet recruiting NCT03018431 - CT Scan and Lung Ultrasonography to Improve Diagnostic of Ventilation Acquired Pneumonia in ICU N/A
Completed NCT02515617 - Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER) N/A
Completed NCT02583308 - Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation N/A
Completed NCT02585180 - Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia N/A
Completed NCT02060045 - Prevention Ventilator Associated Pneumonia N/A
Terminated NCT00543608 - Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Phase 2
Completed NCT02116699 - Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360) N/A