Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00447109




Registration number
NCT00447109
Ethics application status
Date submitted
12/03/2007
Date registered
14/03/2007
Date last updated
14/03/2007

Titles & IDs
Public title
Time Interval for Changing Closed System Suction Catheters, Effect on Ventilator Associated Pneumonia
Scientific title
Endotracheal Suction With or Without Daily Changes of Closed System Suction. Effect on Ventilator Associated Pneumonia and Cost
Secondary ID [1] 0 0
T10308
Secondary ID [2] 0 0
122/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia, Ventilator Associated 0 0
Closed System Suction Catheter 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Closed system suction

Treatment: Devices: Closed system suction
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ventilator-associated pneumonia
Timepoint [1] 0 0
Secondary outcome [1] 0 0
length of hospital
Timepoint [1] 0 0
Secondary outcome [2] 0 0
intensive care stay
Timepoint [2] 0 0
Secondary outcome [3] 0 0
duration of mechanical ventilation
Timepoint [3] 0 0
Secondary outcome [4] 0 0
hospital mortality
Timepoint [4] 0 0
Secondary outcome [5] 0 0
number of acquired organ system derangements
Timepoint [5] 0 0
Secondary outcome [6] 0 0
cost of the closed system suction catheters
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
- Aged greater than 18 years

- Mechanically ventilated for more than 24 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Admitted from other hospital already mechanically ventilated

- Massive haemoptysis

- Previously received mechanical ventilation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deakin University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00447109
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lauren J McTier
Address 0 0
Deakin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00447109