Pneumonia, Ventilator-AssociatedINDEX48NCT01123681
Intubation and Extubation Over 48 Hours Mechanical Ventilation
An observational study of Pneumonia, Ventilator-Associated and Critical Illness, run by Okayama Research Investigator Organizing Network at 6 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Critical Illness
- What is being tested?
- Choice of endotracheal tube
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesJapan
- Study dates
- May 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients in an intensive care unit
Who may be able to join
- Age > 20 years old
- Mechanically ventilated over 48 hours in the ICU
Who cannot join
- Mask ventilation
- Tracheostomy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Intensive Care Unit, Himeji Red Cross Hospital
Himeji, Hyōgo
Intensive Care Unit, Hiroshima City Hospital
Hiroshima, 730-8518
Intensive Crae Unit, Kochi Medical School Hospital
Kochi, 783-8505
Intensive Care Unit, Kagawa Rosai Hospital
Marugame, 763-8502
Intensive Care Unit, Okayama University Hospital
Okayama, 700-8558
Intensive Care Unit, Tsuyama Chuo Hospital
Tsuyama, 708-0841
About this study
Official title: 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.
- Conditions
- Pneumonia, Ventilator-Associated, Critical Illness
- Being tested
- Choice of endotracheal tube
- Keywords
- Respiration, Artificial, Pneumonia, Ventilator-Associated, Critical Illness
- Medical subject headings
- Pneumonia, Ventilator-Associated, Critical Illness, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of endotracheal tubeDevice
Also called Normal cuff without aspiration means Hi-Lo, Normal cuff with aspiration means Hi-Lo Evac, Special cuff with aspiration means Taper Guard
Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration
| Study group | Role | What they receive |
|---|---|---|
| Ventilator associated pneumonia | Not described Receives: Device: Choice of endotracheal tube | |
| No pneumonia | Not described Receives: Device: Choice of endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and timing of ventilator associated pneumonia
From tracheal intubation to ICU duscharge
Measured: one month
Secondary outcomes (3)
Ventilator-free days
During ICU stay
Measured: one month
Duration of ICU stay and hospital stay
From tracheal intubation to ICU or hospital discharge
Measured: three months
ICU and hospital mortality
From tracheal intubation to hospital discharge
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okayama Research Investigator Organizing Network
- Sponsor type
- Research network
- Investigators
- Hiroshi Morimatsu, MD, Ph D, Principal investigator, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123681
- Sponsor's protocol ID
- ORION-INDEX48
- Acronym
- INDEX48
- Status last verified
- Nov 2010
- First submitted
- 9 May 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01123681
- Acronym / sponsor ID
- INDEX48 / ORION-INDEX48
- Conditions
- Pneumonia, Ventilator-Associated, Critical Illness
- Keywords
- Respiration, Artificial, Pneumonia, Ventilator-Associated, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Okayama Research Investigator Organizing NetworkResearch network
- Study start
- May 2010
- Primary completion
- Dec 2010 (estimated)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilator associated pneumonia | – | Device: Choice of endotracheal tube |
| No pneumonia | – | Device: Choice of endotracheal tube |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients in an intensive care unit
Key inclusion criteria (2 listed)
- Age > 20 years old
- Mechanically ventilated over 48 hours in the ICU
Key exclusion criteria (2 listed)
- Mask ventilation
- Tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choice of endotracheal tubeAlso: Normal cuff without aspiration means Hi-Lo, Normal cuff with aspiration means Hi-Lo Evac, Special cuff with aspiration means Taper GuardTypes of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration | Device | No pneumonia, Ventilator associated pneumonia |
Primary outcome
Occurrence and timing of ventilator associated pneumonia
Time frame: one month
From tracheal intubation to ICU duscharge
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
- This is the study homepage written in Japanese.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Morimatsu, MD, Ph D principal investigator
Okayama University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated and Critical Illness, run by Okayama Research Investigator Organizing Network at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and timing of ventilator associated pneumonia (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.