Overview

This trial is active, not recruiting.

Conditions pneumonia, ventilator-associated, critical illness
Treatment choice of endotracheal tube
Sponsor Okayama Research Investigator Organizing Network
Start date May 2010
End date December 2010
Trial size 200 participants
Trial identifier NCT01123681, ORION-INDEX48

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
choice of endotracheal tube Normal cuff without aspiration means Hi-Lo
Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration
choice of endotracheal tube Normal cuff without aspiration means Hi-Lo
Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration

Primary Outcomes

Measure
Occurrence and timing of ventilator associated pneumonia
time frame: one month

Secondary Outcomes

Measure
Ventilator-free days
time frame: one month
Duration of ICU stay and hospital stay
time frame: three months
ICU and hospital mortality
time frame: three months

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Age > 20 years old - Mechanically ventilated over 48 hours in the ICU Exclusion Criteria: - Mask ventilation - Tracheostomy

Additional Information

Official title Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation
Principal investigator Hiroshi Morimatsu, MD, Ph D
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Okayama Research Investigator Organizing Network.