NCT01123681

Brief Summary

The purpose of this study is to determine how often ventilator associated pneumonia happens in the current intensive care units, and how types of endotracheal tube affect its occurrence.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

6 active sites

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

May 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

7 months

First QC Date

May 9, 2010

Last Update Submit

November 12, 2010

Conditions

Keywords

Respiration, ArtificialPneumonia, Ventilator-AssociatedCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Occurrence and timing of ventilator associated pneumonia

    From tracheal intubation to ICU duscharge

    one month

Secondary Outcomes (3)

  • Ventilator-free days

    one month

  • Duration of ICU stay and hospital stay

    three months

  • ICU and hospital mortality

    three months

Study Arms (2)

Ventilator associated pneumonia

Device: Choice of endotracheal tube

No pneumonia

Device: Choice of endotracheal tube

Interventions

Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration

Also known as: Normal cuff without aspiration means Hi-Lo, Normal cuff with aspiration means Hi-Lo Evac, Special cuff with aspiration means Taper Guard
No pneumoniaVentilator associated pneumonia

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients in an intensive care unit

You may qualify if:

  • Age \> 20 years old
  • Mechanically ventilated over 48 hours in the ICU

You may not qualify if:

  • Mask ventilation
  • Tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Intensive Care Unit, Himeji Red Cross Hospital

Himeji, Hyōgo, Japan

Location

Intensive Care Unit, Hiroshima City Hospital

Hiroshima, 730-8518, Japan

Location

Intensive Crae Unit, Kochi Medical School Hospital

Kochi, 783-8505, Japan

Location

Intensive Care Unit, Kagawa Rosai Hospital

Marugame, 763-8502, Japan

Location

Intensive Care Unit, Okayama University Hospital

Okayama, 700-8558, Japan

Location

Intensive Care Unit, Tsuyama Chuo Hospital

Tsuyama, 708-0841, Japan

Location

Related Links

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedCritical IllnessRespiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hiroshi Morimatsu, MD, Ph D

    Okayama University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 9, 2010

First Posted

May 14, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2010

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations