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

Tracking Information

First Received Date ^ICMJE

May 9, 2010

Last Updated Date

November 12, 2010

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Occurrence and timing of ventilator associated pneumonia [ Time Frame: one month ] [ Designated as safety issue: No ]

From tracheal intubation to ICU duscharge

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01123681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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

Intubation and Extubation Over 48 Hours Mechanical Ventilation

Official Title ^ICMJE

Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Critically ill patients in an intensive care unit

Condition ^ICMJE

Pneumonia, Ventilator-Associated
Critical Illness

Intervention ^ICMJE

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

Study Group/Cohort (s)

Ventilator associated pneumonia
Intervention: Device: Choice of endotracheal tube
No pneumonia
Intervention: Device: Choice of endotracheal tube

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

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Mask ventilation
Tracheostomy

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01123681

Other Study ID Numbers ^ICMJE

ORION-INDEX48

Has Data Monitoring Committee

Responsible Party

Hiroshi Morimatsu, Okayama University Hospital

Study Sponsor ^ICMJE

Okayama Research Investigator Organizing Network

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hiroshi Morimatsu, MD, Ph D

Okayama University

Information Provided By

Okayama Research Investigator Organizing Network

Verification Date

November 2010

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

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