Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000103369
Ethics application status
Approved
Date submitted
20/02/2008
Date registered
25/02/2008
Date last updated
29/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Spontaneous versus spontaneous timed mode of assisted ventilation in patients with chest wall disease and stable neuromuscular disease
Scientific title
Spontaneous versus spontaneous timed mode of assisted ventilation in patients with chest wall disease and stable neuromuscular disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular disease 2855 0
Chest wall disease 2856 0
Condition category
Condition code
Respiratory 2988 2988 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to compare 2 commonly used modes of ventilation in patients with respiratory failure from either neuromuscular disease or chest wall disease, such as kyphoscoliosis. The first mode is called "spontaneous mode of pressure supported mechanical ventilation"; where the patient would trigger the ventilator totally on his/ her own; and the second is called "spontaneous timed mode of pressure supported mechanical ventilation"; where the ventilator has a set breath rate but also allows him or her to trigger the ventilator as required. The target population are patients with respiratory failure from neuromuscular disease and chest wall disease, who are already on mechanical ventilation usually in one of these 2 modes described. The patients will remain on each mode of ventilation for a period of 2 weeks, which is followed by a sleep study to assess efficacy of ventilation and sleep quality on each mode. They will also fill out a standardised questionnaire asking them, which mode caused any discomfort, and which one they prefered?. A washout period of 2 weeks will follow the initial mode when the participants will go back on their original ventilator.
Intervention code [1] 2584 0
Treatment: Devices
Comparator / control treatment
This is a crossover study with the patients acting as their own control, comparing the 2 modes of ventilation together.
Control group
Active

Outcomes
Primary outcome [1] 3867 0
Correction of hypoventilation measured as the difference between evening (pre-ventilation) and morning (post-ventilation) PaCO2, and by trends in transcutaneous CO2 measurement across the whole of sleep, and during raid eye movement (REM) sleep periods.
Timepoint [1] 3867 0
Assessed after 14 days of ventilation on each mode
Primary outcome [2] 3868 0
Sleep quality as assessed by the number of events overnight [arousals and apnea hypopnea index (AHI)] and sleep efficiency
Timepoint [2] 3868 0
Assessed after 14 days of ventilation on each mode
Primary outcome [3] 238051 0
Degree of desaturaion as assessed by the total sleep time below 90% and lower. Also the lowest value of desaturation during Non-Rapid Eye Movement sleep (NREM) and Rapid Eye movement sleep (REM).
Timepoint [3] 238051 0
Assessed after 14 days of ventilation on each mode
Secondary outcome [1] 6509 0
Patient preference for mode of ventilation according to a standardised questionnaire
Timepoint [1] 6509 0
Assessed after 14 days of ventilation on each mode
Secondary outcome [2] 6510 0
Patient?s perception of sleep quality according to a standardised questionnaire
Timepoint [2] 6510 0
Assessed after 14 days of ventilation on each mode
Secondary outcome [3] 6511 0
Under-triggering or over-triggering as assessed from the sleep study
Timepoint [3] 6511 0
Assessed after 14 days of ventilation on each mode

Eligibility
Key inclusion criteria
- Patients with chest wall disease such as kyphoscoliosis or stable neuromuscular disease will be eligible
- Patients have evidence of hypoventilation (defined as day time PaCO2 of > 45 mmHg) at the time of initiation of ventilatory support.
- Patients are already on nocturnal assisted ventilation
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients aged less than 18 years of age
- Patients with Chronic Obstructive Pulmonary Disease (COPD)
- Patients with progressive neuromuscular disease such as motor neurone disease
- Patients with a tracheostomy in situ
- Patients in whom we are unable to obtain informed consent

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)
Once patient eligibility is established, subjects will be sent a Patient Information and Consent Form (PICF). An appointment will be made to gain informed consent prior to enrolment. The patients will be randomly allocated either treatment A or B according to a computer generated program. Neither the researchers nor the patients will know which mode of ventilation does A or B represent. Only one unblinded staff member will have access to the computer generated list, which will be kept in a sealed opaque envelope. The same unblinded staff member will also set the blinded patient onto the treatment allocated. The scientist scoring the study as well as the researchers analysing the sleep study data will remain blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be randomly allocated either treatment A or B according to a computer generated program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 584 0
3084

Funding & Sponsors
Funding source category [1] 3107 0
Other
Name [1] 3107 0
Institute for Breathing And Sleep
Country [1] 3107 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing And Sleep
Address
Austin Health
Studley Rd, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 2797 0
None
Name [1] 2797 0
Address [1] 2797 0
Country [1] 2797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5084 0
Austin Health
Ethics committee address [1] 5084 0
Studley Rd, Heidelberg, Vic, 3084
Ethics committee country [1] 5084 0
Australia
Date submitted for ethics approval [1] 5084 0
12/02/2008
Approval date [1] 5084 0
Ethics approval number [1] 5084 0

Summary
Brief summary
The study aims to compare 2 commonly used modes of ventilation in patients with respiratory failure from neuromuscular disease or chest wall disease such as kyphoscoliosis. The study population will be patients already on mechanical ventilation to assist their breathing. As there is no current evidence that one treatment is better than the other, we wish to study the 2 ventilation modes in a crossover design (i.e. one treatment will be followed by the other on each patient) with regards to efficacy of ventilation and sleep quality on each mode. The study hypothesis is that there is no difference between the 2 modes (called the null hypothesis). The study will then attempt to prove whether this is true (i.e. accept the null hypothesis meaning that there is no difference), or false (i.e. reject the null hypothesis meaning that there is a difference between the 2 modes ). The study will help in the long term to determine which mode is more efficacious and comfortable to the patients with neuromuscular or chest wall disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28389 0
Address 28389 0
Country 28389 0
Phone 28389 0
Fax 28389 0
Email 28389 0
Contact person for public queries
Name 11546 0
Dr Murad Ibrahim
Address 11546 0
Austin Health
Studley Rd, Heidelberg, VIC, 3084
Country 11546 0
Australia
Phone 11546 0
03 94965000
Fax 11546 0
Email 11546 0
muradibrahim@hotmail.com
Contact person for scientific queries
Name 2474 0
Dr Murad Ibrahim
Address 2474 0
Austin Health
Studley Rd, Heidelberg, VIC, 3084
Country 2474 0
Australia
Phone 2474 0
03 94965000
Fax 2474 0
Email 2474 0
muradibrahim@hotmail.com

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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