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Trial registered on ANZCTR


Registration number
ACTRN12608000418370
Ethics application status
Approved
Date submitted
21/07/2008
Date registered
25/08/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a 3 second inspiratory time on pattern of ventilation and sputum cleared during manual hyperinflation
Scientific title
Effect of a 3 second inspiratory time during manual hyperinflation compared to current practice, on pattern of ventilation and sputum cleared in patients intubated for at least 2 days.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intubation 3412 0
Condition category
Condition code
Respiratory 3563 3563 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
manual hyperinflation with a 3 second inspiratory time
peak inspiratory pressure limited to 40 cmH2O
6 sets of 6 breaths, once daily over 2 days

therapist trained specifically to perfom manual hyperinflation with 3 second inspiratory time

minimum of 2 hour wash-out period between interventions
Intervention code [1] 3140 0
Treatment: Other
Comparator / control treatment
manual hyperinflation as per current practice
peak inspiratory pressure limited to 40 cmH2O
6 sets of 6 breaths, once daily over 2 days

therapists received no specific instruction/training for the purpose of the study
Control group
Active

Outcomes
Primary outcome [1] 4465 0
wet weight sputum
Timepoint [1] 4465 0
end of day 2
Primary outcome [2] 4466 0
pattern of ventilation - volume delivered, peak inspiratory pressure, peak inspiratory and expiratory flow rates, inspiratory time, inspiratory:expiratory flow rate ratio
Timepoint [2] 4466 0
end of day 2
Secondary outcome [1] 7537 0
nil
Timepoint [1] 7537 0
nil

Eligibility
Key inclusion criteria
intubated for at least 2 days and likely to remain so for the next 2 days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
inability of the person approached for consent to understand English,
head injury with intracranial pressure >/= 15 cmH2O or being managed by hyperventilation,
systolic blood pressure (BP) <100 or > 180 mmHg,
mean arterial blood pressure <70 or > 110 mmHg,
heart rate <70 or >120 bpm,
on inotropic support,
pneumothorax without an intercostal catheter in situ,
subcutaneous emphysema or intercostal catheter with an air leak,
requiring positive expiratory pressure (PEEP) >/= 10 cmH2O during synchronised intermittent mandatory ventilation (SIMV),
on continous positive airway pressure (CPAP) >/= 15 cmH2O and oxygen >50%,
adult respiratory distress syndrome,
acute pulmonary oedema,
acute bronchospasm,
baseline peak inspiratory pressure > 40 cmH2O

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)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
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)

Funding & Sponsors
Funding source category [1] 3619 0
Self funded/Unfunded
Name [1] 3619 0
Address [1] 3619 0
Country [1] 3619 0
Primary sponsor type
Individual
Name
Lyndal Maxwell
Address
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 3253 0
None
Name [1] 3253 0
Address [1] 3253 0
Country [1] 3253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5667 0
Central Sydney Area Health Service Human Research Ethics Committee CRGH Zone
Ethics committee address [1] 5667 0
Concord Research Office
Level 1 Building 75,
Concord Repatriation General Hospital,
Hospital Rd Concord NSW 2139
Ethics committee country [1] 5667 0
Australia
Date submitted for ethics approval [1] 5667 0
Approval date [1] 5667 0
18/11/2002
Ethics approval number [1] 5667 0
CH62/6/2002-094
Ethics committee name [2] 5668 0
Human Research Ethics Committee University of Sydney
Ethics committee address [2] 5668 0
University of Sydney
Research Office
A14 Main Quadrangle
Camperdown Campus
Parramatta Rd NSW 2006
Ethics committee country [2] 5668 0
Australia
Date submitted for ethics approval [2] 5668 0
Approval date [2] 5668 0
13/12/2002
Ethics approval number [2] 5668 0
3617

Summary
Brief summary
Manual hyperinflation is a physiotherapy treatment technique where patients with a breathing tube for artificial (mechanical) ventilation are given a deep breath by squeezing a small bag with an air/oxygen mix. The aim of this study is to investigate whether how physiotherapists perform this technique affects the amount of mucus (phlegm) cleared from the lungs.
Trial website
Trial related presentations / publications
PUBLICATIONS
Maxwell LJ and Ellis ER (2007) Pattern of ventilation during manual hyperinflation performed by physiotherapists. Anaesthesia 62:27-33.

Maxwell LJ, Crosbie J and Ellis ER (2006) The effect of inspiratory time during manual hyperinflation on pattern of ventilation and sputum cleared in intubated patients. eAJP 52 (Supp) S19.

Maxwell LJ, Crosbie J and Ellis ER (2006) Pattern of ventilation in intubated patients during manual hyperinflation with a Mapleson-F circuit. eAJP 52 (Supp) S19.

PRESENTATIONS
Maxwell LJ and Ellis ER (2007) Effect of a 3 second inspiratory time on pattern of ventilation and sputum cleared during manual hyperinflation. 15th International Congress WCPT, Vancouver, Canada.

Maxwell LJ, Crosbie J and Ellis ER (2005) The effect of inspiratory time during manual hyperinflation on pattern of ventilation and sputum cleared in intubated patients. 9th APA National Cardiothoracic Special Group Conference, Melbourne, Australia.

Maxwell LJ, Crosbie and Ellis ER (2005) Pattern of ventilation in intubated patients during manual hyperinflation with a Mapleson-F circuit. 9th APA National Cardiothoracic Special Group Conference, Melbourne, Australia.
Public notes

Contacts
Principal investigator
Name 28752 0
Address 28752 0
Country 28752 0
Phone 28752 0
Fax 28752 0
Email 28752 0
Contact person for public queries
Name 11909 0
Lyndal Maxwell
Address 11909 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 11909 0
Australia
Phone 11909 0
02 9351 9375
Fax 11909 0
Email 11909 0
L.Maxwell@usyd.edu.au
Contact person for scientific queries
Name 2837 0
Lyndal Maxwell
Address 2837 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 2837 0
Australia
Phone 2837 0
02 9351 9375
Fax 2837 0
Email 2837 0
L.Maxwell@usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary