Ventilator-associated Pneumonia (VAP) and Humidification System

This study is currently recruiting participants.

Verified January 2012 by Hospital Sao Domingos

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2012

Last Updated Date

March 6, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

VAP incidence [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01546974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of mechanical ventilation [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ventilator-associated Pneumonia (VAP) and Humidification System

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Ventilator-associated Pneumonia

Intervention ^ICMJE

Device: HME filter Twin Star 55, Drager Medical, Germany
Device: Heated humidification

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

306

Estimated Completion Date

February 2014

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients expected to require mechanical ventilation for at least 48 hours

Exclusion Criteria:

Patients < 18 yo and pregnant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: JOSE R AZEVEDO, MD

55 98 32168110

jrazevedo@elo.com.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01546974

Other Study ID Numbers ^ICMJE

hsd2012, CEP026/2011

Has Data Monitoring Committee

Yes

Responsible Party

José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Study Sponsor ^ICMJE

Hospital Sao Domingos

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

JOSE R AZEVEDO, MD

Director ICU

Information Provided By

Hospital Sao Domingos

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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