Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001213639
Ethics application status
Approved
Date submitted
8/08/2023
Date registered
24/11/2023
Date last updated
24/11/2023
Date data sharing statement initially provided
24/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of using Electrical Impedance Tomography to determine mechanics of ventilation in comparison to standard clinical parameters in patients with high spinal injury T8 and above
Scientific title
The feasibility of using Electrical Impedance Tomography to determine mechanics of ventilation in comparison to standard clinical parameters in patients with high spinal injury T8 and above
Secondary ID [1] 310127 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High spinal cord injury 330693 0
Condition category
Condition code
Injuries and Accidents 327517 327517 0 0
Other injuries and accidents
Neurological 327937 327937 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Electrical Impedance Tomography (EIT) is an emerging technique in the field of respiratory function testing which measures distribution of impedance of electrical currents across the chest. The distribution of impedance can be directly correlated to changes in ventilation distribution allowing for continuous monitoring.



The project will be conducted in compliance with Good Clinical Practice and the applicable regulatory requirements. Subjects will be assessed either by the free or belt electrodes in a single session. Precise positioning of free electrodes is expected to take approximately 30 minutes, while the custom-designed belt will be fitted within 5 minutes.

The treating clinician / treating team will make the initial contact with potential participants regarding research. All patients admitted to Royal Perth ICU will be assessed using their admission diagnosis and medical history. Potential eligible participants are selected based on an inclusion and exclusion criteria.

Subjects will take three deep inspirations to standardise volume history. After a 5 minute interval, breathing will be assessed for 1 minute during which the subject is asked to avoid taking a deep inspiration. This protocol will then be repeated with the subject sitting, supine and laid on left and right side. Each protocol will be performed in a randomised order and include the same volume history manoeuvre and 5 minute equilibration period before each 1 minute recording. A final two protocols will be performed in a seated position where the subject is asked to breath at normal lung volume for 1 minute, followed by a deep inspiration (or deep expiration), before returning to a normal lung volume for a further 1 minute of recording. Each study session is predicted to be completed within 2 hours.

Participants will not need to complete any questionnaires but data regarding their clinical status including heart rate, blood pressure, oxygen requirements, ventilator settings (if applicable) will be collected during the EIT session,

The EIT session will be administered by myself or other trial investigators.

Intervention code [1] 326527 0
Early Detection / Screening
Comparator / control treatment
Information collected will include
- height
- weight
- gender
- age
- chest circumference
- skin fold thickness (caliper)
- level of spinal injury
- injury surgically fixed or not
- ASIA score
- sensory level
- motor level
- MRI findings
- heart rate (telemetry)
- blood pressure (Arterial line or non-invasive oscillatory BP monitor)
- ventilator mode, Peep, Pressure support, Tidal volume, Fi02, Pa02, (via ventilator and arterial blood gas)
- intra abdominal pressure (if present, measured via indwelling bladder catheter),
- total delta impedance, global inhomogeneity index, centre of ventilation, EIT images (measured via EIT)

Standard clinical parameters measured will include level of spinal deficits, ventilatory mechanics (invasive, non-invasive, ventilator settings), intra-abdominal pressure, Pa02/Fi02 ratio and ETC02/ PaCO2 gap
Control group
Active

Outcomes
Primary outcome [1] 335381 0
Total delta impedance measured by EIT
Timepoint [1] 335381 0
Assessed once only during a single observation session
Primary outcome [2] 335854 0
Global inhomogeneity index measured by EIT
Timepoint [2] 335854 0
Assessed once during a single observation session
Primary outcome [3] 335855 0
Centre of ventilation - measured by EIT
Timepoint [3] 335855 0
Assessed once during a single observation session
Secondary outcome [1] 424193 0
Can EIT electrodes and machine be successfully applied to a high spinal patient physically
Will be measured by assessing the fidelity of EIT data
Fidelity of EIT data will be determined by comparing to available lung CT images.
Timepoint [1] 424193 0
Assessed once during a single observation session

Eligibility
Key inclusion criteria
patients with high spinal injuries (T8 and above), including patients that are mechanically ventilated and have lung pathology. All BMIs will be included.
Minimum age
19 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients under the age of 18, patients who do not or cannot consent and patients where placement of electrodes (required for the use of EIT) is impossible.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Change in impedance is measured during the different breathing manoeuvres which will translate into flow and volume between different lung lobes (upper left, lower left, upper right, middle right and lower right). A heterogeneity index will also be derived from the variation in flow between different lung regions. Standard clinical parameters measured will include level of spinal deficits, ventilatory mechanics (invasive, non-invasive, ventilator settings), intra-abdominal pressure, Pa02/Fi02 ratio and ETC02/ PaCO2 gap. This data will be used to assess the correlations between parameters on the EIT with standard clinical parameters

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25176 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 40846 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 314286 0
Hospital
Name [1] 314286 0
Royal Perth Hospital
Country [1] 314286 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 316230 0
None
Name [1] 316230 0
Address [1] 316230 0
Country [1] 316230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313404 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 313404 0
Level 2, Kirkman House, 197 Wellington Street, Royal Perth Hospital, Perth WA 6000
Ethics committee country [1] 313404 0
Australia
Date submitted for ethics approval [1] 313404 0
Approval date [1] 313404 0
11/08/2022
Ethics approval number [1] 313404 0

Summary
Brief summary
The general aim of this pilot study is to establish correlations between parameters of electrical impedance tomography with standard clinical parameters. The specific aims are to:
1.Assess lung ventilation distribution in patients with high spinal injuries (T8 and above)
2.Collect clinical data on ventilatory mechanics including level of spinal deficits, ventilatory mechanics (invasive, non-invasive, ventilator settings) intraabdominal pressure, FiO2 ratio, and end tidal CO2 to arterial CO2 gap
3.Assess correlation between EIT parameters and clinical data

Validity and reliability of EIT systems has been demonstrated in several studies, indicating that EIT may be effective in the assessment of ventilation distribution in patients with asthma, COPD and cystic fibrosis. Furthermore, EIT has also compared well with lung measures such as lung volumes and lung density quantified by CT. However, there is currently little or no studies of the use of EIT in monitoring of patients with restrictive lung disease, in particular patients with spinal injuries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128034 0
Dr June Chen
Address 128034 0
Intensive Care Unit, Royal Perth Hospital, 197 Wellington Street, Perth WA 6000
Country 128034 0
Australia
Phone 128034 0
+61 432259343
Fax 128034 0
Email 128034 0
he19377@health.wa.gov.au
Contact person for public queries
Name 128035 0
Dr June Chen
Address 128035 0
Intensive Care Unit, Royal Perth Hospital, 197 Wellington Street, Perth WA 6000
Country 128035 0
Australia
Phone 128035 0
+61 432259343
Fax 128035 0
Email 128035 0
he19377@health.wa.gov.au
Contact person for scientific queries
Name 128036 0
Dr June Chen
Address 128036 0
Intensive Care Unit, Royal Perth Hospital, 197 Wellington Street, Perth WA 6000
Country 128036 0
Australia
Phone 128036 0
+61 432259343
Fax 128036 0
Email 128036 0
he19377@health.wa.gov.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19703Study protocol    386244-(Uploaded-08-08-2023-03-45-21)-Study-related document.doc
19705Ethical approval    386244-(Uploaded-08-08-2023-03-47-06)-Study-related document.pdf
20117Informed consent form    386244-(Uploaded-23-08-2023-22-04-47)-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.