Intubation and Extubation Over 48 Hours Mechanical Ventilation (INDEX48)

November 12, 2010 updated by: Okayama Research Investigator Organizing Network

Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 730-8518
        • Intensive Care Unit, Hiroshima City Hospital
      • Kochi, Japan, 783-8505
        • Intensive Crae Unit, Kochi Medical School Hospital
      • Marugame, Japan, 763-8502
        • Intensive Care Unit, Kagawa Rosai Hospital
      • Okayama, Japan, 700-8558
        • Intensive Care Unit, Okayama University Hospital
      • Tsuyama, Japan, 708-0841
        • Intensive Care Unit, Tsuyama Chuo Hospital
    • Hyogo
      • Himeji, Hyogo, Japan
        • Intensive Care Unit, Himeji Red Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients in an intensive care unit

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Mask ventilation
  • Tracheostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ventilator associated pneumonia
Device: Choice of endotracheal tube
Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration
Other Names:
  • Normal cuff without aspiration means Hi-Lo
  • Normal cuff with aspiration means Hi-Lo Evac
  • Special cuff with aspiration means Taper Guard
No pneumonia
Device: Choice of endotracheal tube
Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration
Other Names:
  • Normal cuff without aspiration means Hi-Lo
  • Normal cuff with aspiration means Hi-Lo Evac
  • Special cuff with aspiration means Taper Guard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence and timing of ventilator associated pneumonia
Time Frame: one month
From tracheal intubation to ICU duscharge
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free days
Time Frame: one month
During ICU stay
one month
Duration of ICU stay and hospital stay
Time Frame: three months
From tracheal intubation to ICU or hospital discharge
three months
ICU and hospital mortality
Time Frame: three months
From tracheal intubation to hospital discharge
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okayama Research Investigator Organizing Network

Investigators

  • Principal Investigator: Hiroshi Morimatsu, MD, Ph D, Okayama University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

May 9, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

November 16, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORION-INDEX48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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