Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000304932
Ethics application status
Not yet submitted
Date submitted
18/03/2011
Date registered
22/03/2011
Date last updated
22/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection, quantification and differentiation of upper and lower airway obstruction during mechanical ventilation
Scientific title
Detection of upper and lower airway obstruction in patients with normal lungs and chronic obstructive airways disease and asthma while being mechanically ventilated
Secondary ID [1] 259816 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Disease
COAD
Asthma 265397 0
Condition category
Condition code
Respiratory 265553 265553 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of airways resistance in patients that are mechanically ventilated.
Two groups of patients will be selected, patients with normal lungs and patients with lower airway obstruction(COAD and asthma)
Each patient will be placed on controlled mechanical ventilation, in SIMV and progressively smaller diameter endotracheal tubes will be inserted into the existing endotracheal tube for a period of less than one minute.
Measurements of flow and volume and determination of resistance will be determined.
The patients will have these measurements done within an hour.
The patients will be recruited when they are in intensive care. The recruitment will therefore not be planned. Only when patients are deemed suitable candidates by their existing ventilation will a relative be contacted for consent purposes.
Intervention code [1] 264257 0
Not applicable
Comparator / control treatment
Patients with normal lungs
Control group
Active

Outcomes
Primary outcome [1] 262359 0
Determination of airway resistances by analysis of the flow and volume pressure curves from a ventilator. These flow and volumes will be measured after insertion of three progressively decreasing sized endotracheal tubes into already existing endotracheal tubes in an unconscious mechanically ventilated patient.
Timepoint [1] 262359 0
Immediately after decreasing airway resistance for less than one minute.
Secondary outcome [1] 273624 0
The above measurements will be analysed to determine the best marker for upper and lower airway resistances.
Timepoint [1] 273624 0
Analysis after ventilatory waveform data has been recorded.

Eligibility
Key inclusion criteria
Unconscious patients intubated and mechanically ventilated in intensive care.
1 group with normal lungs and 1 group with Chronic obstructive airways disease or asthma
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not under mechanical ventilation in the intensive care environment

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264697 0
Hospital
Name [1] 264697 0
Intensive care department
Country [1] 264697 0
Australia
Primary sponsor type
Hospital
Name
Intensive care department
Address
The Alfred Hospital
Commercial Road Prahran Victoria 3181
Country
Australia
Secondary sponsor category [1] 263831 0
None
Name [1] 263831 0
Address [1] 263831 0
Country [1] 263831 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266691 0
Research and Ethics Unit
Ethics committee address [1] 266691 0
The Alfred Hospital
Commercial Road Prahran 3181
Victoria
Ethics committee country [1] 266691 0
Australia
Date submitted for ethics approval [1] 266691 0
15/03/2011
Approval date [1] 266691 0
Ethics approval number [1] 266691 0

Summary
Brief summary
During mechanical ventilation, increased upper airway resistance may be due to a partial obstruction of the
artificial airway or a large airway abnormality. Increased lower airway resistance is usually due to acute or
chronic airways disease. Either of these problems can lead to increased work of breathing, uncoordinated
ventilator support, respiratory distress and difficulty weaning. Recognition of these problems can lead to
important interventions such as bronchoscopy, artificial airway change or reposition, bronchodilator therapy
and change of ventilation strategy that can improve patient distress and safety. Quantification of these
variables can allow assessment of severity and the response to intervention.
Our hypotheses are that
1. the most valuable variable for quantifying reduced expiratory airflow will be the passive expiratory volume
expired during the first second of expiration PEV1 expressed as a percentage of the Vt (PEV1/Vt ratio). This
is similar to the well recognised standard of FEV1/VC ratio from spirometric quantification of (lower) airflow
obstruction.
2. the most valuable variable for quantifying increased inspiratory resistance during VCV with decelerating
inspiratory flow or during PCV will be the difference between the Paw and calculated Palv during early
inspiration divided by the inspiratory flow at that time.
3. Upper airway obstruction will be distinguished from and lower airway obstruction by a higher inspiratory
resistance relative expiratory resistance
We propose to examine these hypotheses in patients with normal lungs with added inspiratory resistances
and in patients with lower airway obstruction (COAD or asthma) to show whether measurements of flow and
volume are independent of or can account for ventilator pattern (flow rate, flow pattern, tidal volume) and can
recognise and quantify both increasing resistances in large (upper) airways and lower airway obstruction to
distinguish between them.
Methods
Two patient groups will be selected based on the following lung pathology
1. Normal Lungs: 20 mechanically ventilated patients with no significant underlying lung disease and no
significant lung injury will be selected.
Each will be studied to provide a normal values of the resistance measurements.
Then each will be given a series of 3 upper airway resistances for a period of less than a minute to mimic
large airway obstruction (similar to a partially blocked endo-tracheal or tracheostomy tube). This will be
achieved by placing a 10 cm sterilized flexible tube in the endo-tracheal or tracheostomy tube to simulate a
residual diameter equivalent to an ETT size (internal diameter) 6, 4.5 and 3 mm. This is little different to and
carries no more risk than routine patient suctioning where the artificial airway is partly occluded to a similar
degree for a short time
2. Lower airway obstruction (COPD, Asthma): 20 mechanically ventilated patients with known obstructive
airways disease (lower airway obstruction)
Each patient group will be placed in controlled mechanical ventilation and given the same series of
ventilatory patterns to determine the reliability of the measurements of inspiratory and expiratory resistance
measurements under different ventilatory conditions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32360 0
Address 32360 0
Country 32360 0
Phone 32360 0
Fax 32360 0
Email 32360 0
Contact person for public queries
Name 15607 0
David Tuxen
Address 15607 0
Intensive Care , The Alfred, Commercial Rd Prahran,
3181
Victoria
Country 15607 0
Australia
Phone 15607 0
+61 3 90763036
Fax 15607 0
+61 2 90763780
Email 15607 0
[email protected]
Contact person for scientific queries
Name 6535 0
David Tuxen
Address 6535 0
Intensive Care , The Alfred, Commercial Rd Prahran, Victoria
3181
Country 6535 0
Australia
Phone 6535 0
+61 3 90763036
Fax 6535 0
+61 3 90763780
Email 6535 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.