ANZCTR - Registration

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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

Condition category

Condition code

Surgery

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]

None

Comparator / control treatment

Minimal occlusive volume (MOV) technique (control)

Control group

Active

Outcomes

Primary outcome [1]

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]

After a cuff check has been performed when using the minimal occlusive volume technique

Secondary outcome [1]

No secondary outcomes intended for this study.

Timepoint [1]

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?

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]

University

Name [1]

Royal Melbourne Institute of Technology University Emerging Researcher Grant

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Royal Melbourne Institute of Technology University

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Royal Melbourne Hospital

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health-The Royal Melbourne Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/06/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Louise Rose

Address

Division of Nursing & Midwifery
RMIT University
Plenty Rd
PO Box 71
Bundoora

Country

Australia

Phone

03 99257423

Fax

03 94671629

louise.rose@rmit.edu.au

Contact person for scientific queries

Name

Louise Rose

Address

Division of Nursing & Midwifery
RMIT University
Plenty Rd
PO Box 71
Bundoora

Country

Australia

Phone

03 99257423

Fax

03 94671629

louise.rose@rmit.edu.au

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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