Intubation and Extubation Over 48 Hours Mechanical Ventilation

Critical Illness Clinical Trial

— INDEX48  

Official title:

Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01123681
• Other study ID #: ORION-INDEX48
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2010
• Last updated: November 12, 2010
• Start date: May 2010

Study information

• Verified date: November 2010
• Source: Okayama Research Investigator Organizing Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age > 20 years old

• Mechanically ventilated over 48 hours in the ICU

Exclusion Criteria:

• Mask ventilation

• Tracheostomy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

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

Locations

Country	Name	City	State
Japan	Intensive Care Unit, Himeji Red Cross Hospital	Himeji	Hyogo
Japan	Intensive Care Unit, Hiroshima City Hospital	Hiroshima
Japan	Intensive Crae Unit, Kochi Medical School Hospital	Kochi
Japan	Intensive Care Unit, Kagawa Rosai Hospital	Marugame
Japan	Intensive Care Unit, Okayama University Hospital	Okayama
Japan	Intensive Care Unit, Tsuyama Chuo Hospital	Tsuyama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama Research Investigator Organizing Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence and timing of ventilator associated pneumonia	From tracheal intubation to ICU duscharge	one month	No
Secondary	Ventilator-free days	During ICU stay	one month	No
Secondary	Duration of ICU stay and hospital stay	From tracheal intubation to ICU or hospital discharge	three months	No
Secondary	ICU and hospital mortality	From tracheal intubation to hospital discharge	three months	No

External Links

•   This is the study homepage written in Japanese.