Trial Review

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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
Date results information initially provided
19/09/2023
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
Scientific title
NutritiOn inTake and physIcal recovery for Critically ill patiEnts requiring non-invasive forms of respiratory support
Secondary ID [1] 307689 0
None
Universal Trial Number (UTN)
Trial acronym
NOTICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critical illness 327235 0
non-invasive respiratory support 327236 0
Condition category
Condition code
Diet and Nutrition 324374 324374 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 324164 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332172 0
The primary outcome is change in quadriceps muscle layer thickness using ultrasonography.
Timepoint [1] 332172 0
This will be assessed on day 1 (study inclusion) and on day 7.
Secondary outcome [1] 412465 0
Change in mean energy intake (kilocalories) from 24-hr diet recalls and food record charts completed by nursing staff (where required).
Timepoint [1] 412465 0
This will be assessed at study inclusion (day 1), on day 4 (+/-1 day), and on day 7.
Secondary outcome [2] 412466 0
Change in mean protein intake (grams) from 24-hr diet recalls and food record charts completed by nursing staff (where required).
Timepoint [2] 412466 0
This will be assessed on study inclusion (day 1), on day 4 (+/- 1 day), and on day 7.
Secondary outcome [3] 412467 0
Change in handgrip strength using a dynamometer
Timepoint [3] 412467 0
This will be assessed at study inclusion (day 1) and on day 7.
Secondary outcome [4] 412468 0
Change in nutrition status using the Patient-Generated Subjective Global Assessment
Timepoint [4] 412468 0
This will be assessed at study inclusion (day 1) and on day 7.
Secondary outcome [5] 412469 0
Change in functional outcome using the Barthel Index
Timepoint [5] 412469 0
This will be assessed at study inclusion (day 1) and on day 90.
Secondary outcome [6] 412470 0
Quality of life using the Euro-Qol-Five-Dimension-Five-Level questionnaire
Timepoint [6] 412470 0
This will be assessed on day 90 post study inclusion.
Secondary outcome [7] 412471 0
Functional capacity using the World Health Organisation Disability Assessment Score
Timepoint [7] 412471 0
This will be assessed on day 90 post study inclusion.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/08/2022
Date of last participant enrolment
Anticipated
31/08/2023
Actual
19/05/2023
Date of last data collection
Anticipated
30/11/2023
Actual
29/08/2023
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22899 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 38206 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 311959 0
University
Name [1] 311959 0
The University of Adelaide
Country [1] 311959 0
Australia
Primary sponsor type
Individual
Name
Dr Lee-anne Chapple
Address
Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 313445 0
None
Name [1] 313445 0
Address [1] 313445 0
Country [1] 313445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311389 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 311389 0
Level 3, Roma Mitchell Building
136 North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 311389 0
Australia
Date submitted for ethics approval [1] 311389 0
Approval date [1] 311389 0
20/07/2022
Ethics approval number [1] 311389 0
16552

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120922 0
Dr Lee-anne Chapple
Address 120922 0
Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 120922 0
Australia
Phone 120922 0
+61 8 7074 1763
Fax 120922 0
Email 120922 0
lee-anne.chapple@adelaide.edu.au
Contact person for public queries
Name 120923 0
Dr Lee-anne Chapple
Address 120923 0
Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 120923 0
Australia
Phone 120923 0
+61 8 7074 1763
Fax 120923 0
Email 120923 0
lee-anne.chapple@adelaide.edu.au
Contact person for scientific queries
Name 120924 0
Dr Lee-anne Chapple
Address 120924 0
Intensive Care Unit
The Royal Adelaide Hospital
Port Road
Adelaide
South Australia 5000
Country 120924 0
Australia
Phone 120924 0
+61 8 7074 1763
Fax 120924 0
Email 120924 0
lee-anne.chapple@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.