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Trial registered on ANZCTR


Registration number
ACTRN12607000339459
Ethics application status
Approved
Date submitted
7/06/2007
Date registered
26/06/2007
Date last updated
26/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Minimal Occlusive Volume (MOV) technique compared to Cuff Pressure Monitoring (CPM) in Endotracheal and Tracheal Cuff Management
Scientific title
A Randomised Controlled Trial of Minimal Occlusive Volume (MOV) technique compared to Cuff Pressure Monitoring (CPM) in Endotracheal and Tracheal Cuff Management
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspiration of orophayngeal secretions during cuff monitoring procedures 1890 0
Condition category
Condition code
Surgery 1985 1985 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to have the cuff monitoring procedure performed either by the minimal occlusive volume (MOV) technique (control) or by cuff pressure monitoring following insertion of blue dye into the oropharynx. Presence of gross aspiration of blue dye will be ascertained via suctioning of tracheal secretions post cuff monitoring procedure. The insertion of blue dye to assess aspiration will be conducted once only on each participant.
Intervention code [1] 1812 0
None
Comparator / control treatment
Minimal occlusive volume (MOV) technique (control)
Control group
Active

Outcomes
Primary outcome [1] 2806 0
Determine whether there is a difference in the gross aspiration of blue dye stained oropharyngeal secretions after a cuff check has been performed when using the minimal occlusive volume technique compared to cuff pressure monitoring.
Timepoint [1] 2806 0
After a cuff check has been performed when using the minimal occlusive volume technique
Secondary outcome [1] 4731 0
No secondary outcomes intended for this study.
Timepoint [1] 4731 0

Eligibility
Key inclusion criteria
Patients receiving mechanical ventilation for >8 hours. . Patients with known allergy to food dye will be excluded from the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be assigned to either minimal occlusive volume technique or cuff pressure monitoring according to a computer-generated randomisation list once the entry criteria have been determined by the study investigators. Randomisation allocation will be concealed within separate, numbered, opaque, sealed envelopes and opened by the investigators once the eligibility criteria has been ascertained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned to either minimal occlusive volume technique or cuff pressure monitoring according to a computer-generated randomisation list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
186
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2125 0
University
Name [1] 2125 0
Royal Melbourne Institute of Technology University Emerging Researcher Grant
Country [1] 2125 0
Australia
Primary sponsor type
Other
Name
Royal Melbourne Institute of Technology University
Address
Country
Australia
Secondary sponsor category [1] 1932 0
Hospital
Name [1] 1932 0
The Royal Melbourne Hospital
Address [1] 1932 0
Country [1] 1932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3920 0
Melbourne Health-The Royal Melbourne Hospital
Ethics committee address [1] 3920 0
Ethics committee country [1] 3920 0
Australia
Date submitted for ethics approval [1] 3920 0
Approval date [1] 3920 0
06/06/2007
Ethics approval number [1] 3920 0
2007.077

Summary
Brief summary
Mechanical ventilation is a life saving treatment that is used every day in Intensive Care for people with serious breathing difficulties. In order to provide mechanical ventilation, it is necessary to insert a tube into the trachea (windpipe). This tube has a balloon around its tip that must be inflated to enable the provision of mechanical ventilation, and prevents oral secretions entering the lower airways, which potentially may cause ventilator-associated pneumonia.

The level of inflation of this cuff needs ongoing monitoring (performed 8 hourly) to prevent both secretion aspiration (entry of fluid into the lungs) due to under-inflation, and damage to the tracheal lining due to excessive pressure from over-inflation. Currently, there are two primary methods in use to monitor over and under inflation within Australasia.

The minimal occlusive volume technique (MOV) involves addition or removal of sufficient air in the cuff to abolish an air leak. This technique requires deflation of the cuff in order to assess the appropriateness of the cuff inflation volume which may increase the risk of saliva and other secretions entering the lungs. Cuff pressure monitoring measures the pressure within the cuff via a cuff manometer. Titration of the cuff pressure may be performed by addition or withdrawal of small increments of air with a syringe. Full deflation of the cuff is not required. However, the appropriateness of cuff pressure monitoring has been questioned as pressures are influenced by changes in patients’ position and condition. Therefore there is the risk that the cuff may be under inflated for periods of time.

The proposed study aims to determine whether there is a detectable difference in the aspiration of blue dye stained secretions when comparing the two techniques; MOV and cuff pressure monitoring. Testing of aspiration of secretions using blue dye is routinely performed in testing for aspiration in patients with swallowing difficulties. Patients will be randomised to have their routine cuff management check performed by either the MOV technique or cuff pressure monitoring. Prior to the procedure, blue dye will be placed on the tongue, routine suctioning will then identify the presence of dye within the patient’s tracheal secretions.

There will be minimal risk to patients because both cuff management techniques and the use of blue dye to assess aspiration conform with current international clinical practice guidelines based on sound scientific principles. The potential benefit of the study is to identify the level of aspiration associated with either technique in order to inform current practice guidelines that may assist in the prevention of ventilator associated pneumonia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27915 0
Address 27915 0
Country 27915 0
Phone 27915 0
Fax 27915 0
Email 27915 0
Contact person for public queries
Name 11001 0
Louise Rose
Address 11001 0
Division of Nursing & Midwifery
RMIT University
Plenty Rd
PO Box 71
Bundoora
Country 11001 0
Australia
Phone 11001 0
03 99257423
Fax 11001 0
03 94671629
Email 11001 0
[email protected]
Contact person for scientific queries
Name 1929 0
Louise Rose
Address 1929 0
Division of Nursing & Midwifery
RMIT University
Plenty Rd
PO Box 71
Bundoora
Country 1929 0
Australia
Phone 1929 0
03 99257423
Fax 1929 0
03 94671629
Email 1929 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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