NCT01546974

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
306

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 7, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

March 3, 2012

Last Update Submit

March 6, 2012

Conditions

Ventilator-associated Pneumonia

Keywords

Mechanical VentilationHumidification systemPatients submitted to mechanical ventilation for at least 48 hours

Outcome Measures

Primary Outcomes (1)

  • VAP incidence

Secondary Outcomes (1)

  • Duration of mechanical ventilation

Study Arms (2)

HME filter

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

Heated humidificator MR 730 Fisher & Paykel

EXPERIMENTAL
Device: Heated humidification

Interventions

HME filter Twin Star 55, Drager Medical, GermanyDEVICE
HME filter
Heated humidificationDEVICE
Heated humidificator MR 730 Fisher & Paykel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients \< 18 yo and pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-000, Brazil

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JOSE R AZEVEDO, MD

    Director ICU

    STUDY CHAIR

Central Study Contacts

JOSE R AZEVEDO, MD

CONTACT

55 98 32168110jrazevedo@elo.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator ICU

Study Record Dates

First Submitted

March 3, 2012

First Posted

March 7, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

March 7, 2012

Record last verified: 2012-01

Locations

BR(1)