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Trial registered on ANZCTR
Registration number
ACTRN12622001155785
Ethics application status
Approved
Date submitted
3/08/2022
Date registered
23/08/2022
Date last updated
19/09/2023
Date data sharing statement initially provided
23/08/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
NutritiOn inTake and physIcal recovery for Critically ill patiEnts requiring non-invasive forms of respiratory support
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Scientific title
NutritiOn inTake and physIcal recovery for Critically ill patiEnts requiring non-invasive forms of respiratory support
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Secondary ID [1]
307689
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None
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Universal Trial Number (UTN)
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Trial acronym
NOTICE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
critical illness
327235
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non-invasive respiratory support
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Condition category
Condition code
Diet and Nutrition
324374
324374
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients admitted to the Intensive Care Unit who receive non-invasive forms of respiratory support (non-invasive ventilation or high-flow oxygen therapy) as their first form of respiratory therapy will be included in this study. Nutrition intake at days 1, 3-5, and 7 after study inclusion will be observed, and change in physical and functional capacity from days 1 to 7 and at day 90 post admission assessed.
The study involves active participation for patients through the use of a dynamometer for hand grip strength and completion of questionnaires. It is anticipated that patients participation at each time point will take:
Day 1: ultrasonography of the Quadricep Muscle Layer Thickness (QMLT), handgrip strength using a dynamometer, 24-hour diet recall, nutrition status assessment using the Patient-generated subjective global assessment, and Barthel Index regarding functional capacity, total ~30-40 minutes
Day 3-5: 24-hr diet recall, total ~10-15 minutes
Day 7: ultrasonography of the QMLT, handgrip strength using a dynamometer, 24-hour diet recall, nutrition status assessment using the Patient-generated subjective global assessment, total ~30-40 minutes
Day 90: 24-hour diet recall, functional capacity using the Barthel Index, quality of life using the Euro-Qol-5D-5L and disability using the WHODAS 2.0, total ~20-30 minutes
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Intervention code [1]
324164
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Diagnosis / Prognosis
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome is change in quadriceps muscle layer thickness using ultrasonography.
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Assessment method [1]
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Timepoint [1]
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This will be assessed on day 1 (study inclusion) and on day 7.
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Secondary outcome [1]
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Change in mean energy intake (kilocalories) from 24-hr diet recalls and food record charts completed by nursing staff (where required).
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Assessment method [1]
412465
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Timepoint [1]
412465
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This will be assessed at study inclusion (day 1), on day 4 (+/-1 day), and on day 7.
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Secondary outcome [2]
412466
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Change in mean protein intake (grams) from 24-hr diet recalls and food record charts completed by nursing staff (where required).
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Assessment method [2]
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Timepoint [2]
412466
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This will be assessed on study inclusion (day 1), on day 4 (+/- 1 day), and on day 7.
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Secondary outcome [3]
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Change in handgrip strength using a dynamometer
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Assessment method [3]
412467
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Timepoint [3]
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This will be assessed at study inclusion (day 1) and on day 7.
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Secondary outcome [4]
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Change in nutrition status using the Patient-Generated Subjective Global Assessment
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Assessment method [4]
412468
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Timepoint [4]
412468
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This will be assessed at study inclusion (day 1) and on day 7.
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Secondary outcome [5]
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Change in functional outcome using the Barthel Index
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Assessment method [5]
412469
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Timepoint [5]
412469
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This will be assessed at study inclusion (day 1) and on day 90.
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Secondary outcome [6]
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Quality of life using the Euro-Qol-Five-Dimension-Five-Level questionnaire
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Assessment method [6]
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Timepoint [6]
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This will be assessed on day 90 post study inclusion.
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Secondary outcome [7]
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Functional capacity using the World Health Organisation Disability Assessment Score
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Assessment method [7]
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Timepoint [7]
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This will be assessed on day 90 post study inclusion.
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Eligibility
Key inclusion criteria
i) First admission to the RAH ICU this hospital episode
ii) Are 18 years of age or over
iii) Have or are expected to receive non-invasive ventilation or high-flow oxygen therapy while in the ICU
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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
i) Patients expected to be unable to follow commands and give informed consent at any point throughout the study (ie: significant head injury/stroke/neurosurgical intervention)
ii) Pregnant
iii) Receiving non-invasive respiratory support post extubation from invasive mechanical ventilation
iv) Utilising non-invasive respiratory support for the purposes of previously diagnosed Obstructive Sleep Apnoea
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
This is a pilot study, in which data will be used to calculate a sample size for a larger prospective trial.
Continuous data will be presented as mean (standard deviation) and as number (percentages) for categorical data. The primary outcome (change in QMLT from study inclusion to day 7) will be analysed using t-tests.
Appropriate statistical tests will be used to compare change data from study inclusion to day 7 and from study inclusion to day 90.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
17/08/2022
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Date of last participant enrolment
Anticipated
31/08/2023
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Actual
19/05/2023
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Date of last data collection
Anticipated
30/11/2023
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Actual
29/08/2023
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
22899
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
38206
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Adelaide
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Address [1]
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North Terrace
Adelaide 5000
South Australia
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Country [1]
311959
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Australia
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Primary sponsor type
Individual
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Name
Dr Lee-anne Chapple
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Address
Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
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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]
313445
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Address [1]
313445
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Country [1]
313445
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
311389
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Central Adelaide Local Health Network Human Research Ethics Committee
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Ethics committee address [1]
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Level 3, Roma Mitchell Building 136 North Terrace Adelaide South Australia 5000
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Ethics committee country [1]
311389
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Australia
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Date submitted for ethics approval [1]
311389
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Approval date [1]
311389
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20/07/2022
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Ethics approval number [1]
311389
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16552
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Summary
Brief summary
Patients admitted to the Intensive care Unit (ICU) are the sickest in hospital, and those that survive experience significant muscle wasting and poor functional outcomes. Nutrition therapy is a fundamental part of clinical care that is thought important to optimise recovery. Historically, invasive mechanical ventilation (IMV) – the insertion of a tube into the trachea to support or replace spontaneous breathing – has been a key strategy in respiratory management; however, for certain causes of respiratory failure there has been increasing use of non-invasive techniques. Current international critical care nutrition guidelines largely focus on those patients that are receiving IMV, and guidance in the setting of non-invasive ventilation (NIV) is lacking. This is partly due to limited high-quality nutritional and functional outcome data in this population group. We propose undertaking a prospective observational study to quantify both nutrition intake and physical and functional outcomes in critically ill patients receiving non-invasive respiratory support.
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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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Dr Lee-anne Chapple
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Address
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Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
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Country
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Australia
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Phone
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+61 8 7074 1763
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Lee-anne Chapple
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Address
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Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
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Country
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Australia
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Phone
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+61 8 7074 1763
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Lee-anne Chapple
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Address
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Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
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Country
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Australia
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Phone
120924
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+61 8 7074 1763
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Fax
120924
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Email
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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
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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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