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Intubation and Extubation Over 48 Hours Mechanical Ventilation (INDEX48)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Okayama Research Investigator Organizing Network.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Okayama Research Investigator Organizing Network
ClinicalTrials.gov Identifier:
NCT01123681
First received: May 9, 2010
Last updated: November 12, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Pneumonia, Ventilator-Associated
Critical Illness
 Device: Choice of endotracheal tube

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Okayama Research Investigator Organizing Network:

Primary Outcome Measures:
  • Occurrence and timing of ventilator associated pneumonia [ Time Frame: one month ] [ Designated as safety issue: No ]
    From tracheal intubation to ICU duscharge


Secondary Outcome Measures:
  • Ventilator-free days [ Time Frame: one month ] [ Designated as safety issue: No ]
    During ICU stay

  • Duration of ICU stay and hospital stay [ Time Frame: three months ] [ Designated as safety issue: No ]
    From tracheal intubation to ICU or hospital discharge

  • ICU and hospital mortality [ Time Frame: three months ] [ Designated as safety issue: No ]
    From tracheal intubation to hospital discharge


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically ill patients in an intensive care unit

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Mask ventilation
  • Tracheostomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123681

Locations
Japan
Intensive Care Unit, Himeji Red Cross Hospital
Himeji, Hyogo, Japan
Intensive Care Unit, Hiroshima City Hospital
Hiroshima, Japan, 730-8518
Intensive Crae Unit, Kochi Medical School Hospital
Kochi, Japan, 783-8505
Intensive Care Unit, Kagawa Rosai Hospital
Marugame, Japan, 763-8502
Intensive Care Unit, Okayama University Hospital
Okayama, Japan, 700-8558
Intensive Care Unit, Tsuyama Chuo Hospital
Tsuyama, Japan, 708-0841
Sponsors and Collaborators
Okayama Research Investigator Organizing Network
Investigators
Principal Investigator: Hiroshi Morimatsu, MD, Ph D Okayama University
  More Information

Additional Information:
This is the study homepage written in Japanese.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hiroshi Morimatsu, Okayama University Hospital
ClinicalTrials.gov Identifier: NCT01123681     History of Changes
Other Study ID Numbers: ORION-INDEX48
Study First Received: May 9, 2010
Last Updated: November 12, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Okayama Research Investigator Organizing Network:
Respiration, Artificial
Pneumonia, Ventilator-Associated
Critical Illness

Additional relevant MeSH terms:
Critical Illness
Pneumonia
Pneumonia, Ventilator-Associated
Disease Attributes
Pathologic Processes
Lung Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on June 17, 2013