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Trial registered on ANZCTR
Registration number
ACTRN12619000148178
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
1/02/2019
Date last updated
12/07/2022
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Determining the Safety and Benefits of Exercising Patients with a Tracheostomy and a Speaking Valve
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Scientific title
Determining the Safety and Benefits of Exercising Tracheostomised Mechanically Ventilated Patients with Passy-Muir Speaking Valves
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Secondary ID [1]
295767
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Nil known.
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Universal Trial Number (UTN)
U1111-1218-7163
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Dysfunction
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Condition category
Condition code
Respiratory
308045
308045
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The exercise component will include five minutes of MOTOmed Letto cycling (administered and supervised by a trained intensive care physiotherapist), starting with a resistance of zero and increasing the resistance by one level each minute. The MOTOmed® Letto is a lower limb cycle ergometer that allows the lower limbs to be trained passively, motor-assisted and actively. The patient can exercise either lying in bed or sitting in a chair. The exercise will cease at five minutes or if any serious adverse events occur.
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Intervention code [1]
312093
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Rehabilitation
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Comparator / control treatment
The comparator will be patients exercising without a speaking valve versus patients with the speaking valve.
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Control group
Active
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Outcomes
Primary outcome [1]
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End expiratory lung volumes (EELV) will be assessed using data from the PulmoVista® 500 Electrical Impedance Tomography machine. Data will be analysed offline post data collection using commercially available Draeger software (Draeger EIT Data Analysis Tool 6.1).
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Assessment method [1]
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Timepoint [1]
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Baseline, during exercise and 30 minutes post exercise (primary endpoint).
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Primary outcome [2]
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End expiratory lung impedence (EELI) will be assessed using data from the PulmoVista® 500 Electrical Impedance Tomography machine. Data will be analysed offline post data collection using commercially available Draeger software (Draeger EIT Data Analysis Tool 6.1).
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Assessment method [2]
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Timepoint [2]
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Baseline, during exercise and 30 minutes post exercise (primary endpoint).
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Primary outcome [3]
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Rib cage and abdominal mobility via abdominal-to-chest ratio (A:C) via Respiratory Inductive Plethysmography (RIP) equipment, which includes two belts, one thoracic and one abdominal.
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Assessment method [3]
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Timepoint [3]
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Baseline, during exercise and 30 minutes post exercise (primary endpoint).
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Secondary outcome [1]
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Rating of perceived exertion (RPE) via a modified Borg scale
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Assessment method [1]
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Timepoint [1]
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Baseline.
During exercise.
30 minutes post exercise.
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Secondary outcome [2]
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Distance completed as provided by the ergometer.
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Assessment method [2]
350948
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Timepoint [2]
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Immediately post exercise
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Secondary outcome [3]
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Heart rate (HR) using electrical cardiogram.
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Assessment method [3]
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Timepoint [3]
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Baseline.
During exercise.
30 minutes post exercise.
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Secondary outcome [4]
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End tidal carbon dioxide (EtCO2) will be assessed via a FilterLine® Set CO2 Sampling Line within the ventilation circuit.
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Assessment method [4]
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Timepoint [4]
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Baseline.
During exercise.
30 minutes post exercise.
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Secondary outcome [5]
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Peripheral capillary oxygen saturation (SpO2) via pulse oximetry.
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Assessment method [5]
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Timepoint [5]
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Baseline.
During exercise.
30 minutes post exercise.
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Eligibility
Key inclusion criteria
• Adult patients admitted to ICU with a tracheostomy.
• Adult patients admitted to a hospital ward or discharged to a ward from ICU with a tracheostomy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Age under 18
• Patients unable or unwilling to provide informed consent
• Injuries to lower limbs preventing them from being able to participate in exercise therapy
• Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs and/or has lower limb movement restrictions preventing them from being able to do cycle ergometry
• Cardiovascular instability as determined clinically by the treating therapist or medical staff
• Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury)
• Death is deemed imminent and inevitable
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be analysed offline post data collection using commercially available Draeger software (Draeger EIT Data Analysis Tool 6.1). EELI will be averaged across the readings and displayed as mean EELI for each of the four data collection periods. To compare two groups over time periods, a generalised linear mixed model will be used for RR, EtCO2, HR and SpO2. The level of significance will be set at p <0.05 throughout, with 95 % confidence intervals quoted where appropriate. All statistical analyses will be conducted using a data program such as STATATM.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2021
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Actual
19/05/2021
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Date of last participant enrolment
Anticipated
28/02/2023
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Actual
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Date of last data collection
Anticipated
28/02/2023
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Actual
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Sample size
Target
20
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Accrual to date
4
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
23780
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4032 - Chermside
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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The Prince Charles Hospital
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Address [1]
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Rode Rd,
Chermside, QLD, 4032
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Physiotherapy Department - The Prince Charles Hospital
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Address
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD, 4032
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
299798
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Address [1]
299798
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Country [1]
299798
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Prince Charles Hospital Human Research Ethics Committee
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Ethics committee address [1]
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Building 14
Rode Road
CHERMSIDE QLD 4032
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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06/08/2018
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Approval date [1]
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14/08/2018
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Ethics approval number [1]
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HREC/18/QPCH/183
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Summary
Brief summary
The focus of this study is to determine the safety and benefits of exercising patients who are mechanically ventilated via a tracheostomy whilst using a Passy-Muir speaking valve. The benefits of early exercise for patients in ICU have been well documented including: decreased ICU length of stay (LOS), hospital LOS and more ventilator-free days. Furthermore for tracheostomised patients, the benefits of utilising speaking valves (SVs) include: less accumulated secretions, decreased carbon dioxide retention, decreased respiratory rate, improved lung recruitment and greater verbal communication. Unfortunately the use of SVs has been limited due to concerns of lung derecruitment during a period of cuff deflation or conversely in some patients, hyperinflation. Fortunately recent studies have addressed these safety concerns by demonstrating that SVs did not cause derecruitment or hyperinflation of the lung, rather resulted in improved lung recruitment. It is important to note that these studies were completed with patients at rest, therefore the effect on the lungs during physiotherapy or exercise still needs to be investigated.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Luke Churchill
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Address
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The Prince Charles Hospital,
Physiotherapy Department,
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD,
4032
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Country
86082
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Australia
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Phone
86082
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+61 7 31395310
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Fax
86082
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Email
86082
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[email protected]
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Contact person for public queries
Name
86083
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Mr Luke Churchill
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Address
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The Prince Charles Hospital,
Physiotherapy Department,
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD,
4032
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Country
86083
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Australia
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Phone
86083
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+61 7 31395310
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Fax
86083
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Email
86083
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[email protected]
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Contact person for scientific queries
Name
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Mr Luke Churchill
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Address
86084
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The Prince Charles Hospital,
Physiotherapy Department,
Ground Floor, Main Building,
Rode Rd,
Chermside, QLD,
4032
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Country
86084
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Australia
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Phone
86084
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+61 7 31395310
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Fax
86084
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Email
86084
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data that is collected during the project will be reidentifiable via a coding system and not of an individual nature.
Information linking named participants to these code numbers will be kept separately from any research databases and destroyed once data collection has been completed. We will ensure that all data subject to analysis and archiving is nonidentifiable in any final publications or presentations.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
921
Informed consent form
375756-(Uploaded-02-01-2019-16-34-17)-Study-related document.docx
922
Study protocol
375756-(Uploaded-02-01-2019-16-37-46)-Study-related document.docx
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.
Download to PDF