Pneumonia, Ventilator AssociatedNCT00447109
Time Interval for Changing Closed System Suction Catheters, Effect on Ventilator Associated Pneumonia
A study testing Closed system suction in people with Pneumonia, Ventilator Associated and Closed System Suction Catheter, run by Bayside Health at 1 site in Australia.
Trial summary
The purpose of this study was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Ventilator Associated, Closed System Suction Catheter
- What is being tested?
- Closed system suction
- Type of treatment
- Medical device
- How many people
- 344 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2003to Apr 2004
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged greater than 18 years
- Mechanically ventilated for more than 24 hours
Who cannot join
- Admitted from other hospital already mechanically ventilated
- Massive haemoptysis
- Previously received mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endotracheal Suction With or Without Daily Changes of Closed System Suction. Effect on Ventilator Associated Pneumonia and Cost
The purpose of this study was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.
Read the detailed description
Comparison(s): the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.
- Being tested
- Closed system suction
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed system suctionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-associated pneumonia
Secondary outcomes (6)
length of hospital
intensive care stay
duration of mechanical ventilation
hospital mortality
number of acquired organ system derangements
cost of the closed system suction catheters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startSep 2003
- Study completionApr 2004
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 344 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Deakin University
- Investigators
- Lauren J McTier, Principal investigator, Deakin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447109
- Sponsor's protocol ID
- 122/02
- Other IDs
- T10308
- Status last verified
- Mar 2007
- First submitted
- 12 Mar 2007
- Last updated
- 14 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Suction With or Without Daily Changes of Closed System Suction. Effect on Ventilator Associated Pneumonia and Cost
- ClinicalTrials.gov ID
- NCT00447109
- Acronym / sponsor ID
- 122/02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Deakin University
- Study start
- Sep 2003
- Study completion
- Apr 2004
- First posted
- 14 Mar 2007 (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 was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.
Detailed description
Comparison(s): the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged greater than 18 years
- Mechanically ventilated for more than 24 hours
Key exclusion criteria (3 listed)
- Admitted from other hospital already mechanically ventilated
- Massive haemoptysis
- Previously received mechanical ventilation
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 |
|---|---|---|
| Closed system suction | Device | – |
Primary outcome
ventilator-associated pneumonia
6 secondary outcomes
length of hospital
intensive care stay
duration of mechanical ventilation
hospital mortality
number of acquired organ system derangements
cost of the closed system suction catheters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2007.
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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.
Lauren J McTier principal investigator
Deakin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed system suction in people with Pneumonia, Ventilator Associated and Closed System Suction Catheter, run by Bayside Health at 1 site in Australia.
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 3 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: finished, as of the sponsor's last update on 14 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ventilator-associated pneumonia. 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 14 Mar 2007.