Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001364561
Ethics application status
Approved
Date submitted
7/08/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
EIT - Electrical impedance tomography assessment of lung homogeneity in infants undergoing inguinal hernia surgery; a prospective cohort study
Scientific title
Electrical impedance tomography assessment of lung homogeneity in infants undergoing inguinal hernia surgery; a prospective cohort study
Secondary ID [1] 311632 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung function during surgery 333072 0
inguinal hernia surgery 334726 0
Condition category
Condition code
Respiratory 329761 329761 0 0
Other respiratory disorders / diseases
Anaesthesiology 331418 331418 0 0
Anaesthetics
Surgery 332177 332177 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will use EIT (Electrical Impedance Topography) to define the patterns of tidal ventilation within the chest in infants undergoing inguinal hernia surgery with four different anaesthetic types, 1. spinal 2. caudal, sedation and high flow nasal oxygen 3. general anaesthesia with a supraglottic airway 4. general anesthesia with mechanical ventilation via an endotracheal tube. EIT is a non-invasive, radiation-free monitoring tool that allows real-time continuous imaging of ventilation at the bedside, measuring the impedance of the thorax through a belt placed around patient's chest. The belt will be placed on the patient by a member of the research team preoperatively. Five measurements will be taken, 1. preoperative baseline recording 2. after the commencement of anaesthesia just prior to knife to skin 3. at the end of surgical procedure prior to end anaesthesia (i.e when dressings being applied) 4. within 10 minutes from arrival to recovery/intensive care unit 5. just before discharge from recovery ward (or two hours post operatively if discharged directly from theatre to Neonatal Intensive Care/ Special Care Unit). The EIT device is not part of usual monitoring of infants in this setting and is being specifically utilised for this study to assess ventilation patterns.
Intervention code [1] 328092 0
Diagnosis / Prognosis
Comparator / control treatment
Lung homogeneity will be assessed in four different types of anaesthetic techniques and comparisons will be made between all four of them to determine the different patterns of ventilation, if present.
Control group
Active

Outcomes
Primary outcome [1] 337541 0
Evaluate the impact of different anaesthesia types on lung homogeneity in neonates and infants undergoing inguinal hernia repair
Timepoint [1] 337541 0
1. Preoperative baseline recording 2. After the commencement of anaesthesia just prior to knife to skin 3. At the end of surgical procedure prior to end anaesthesia (i.e when dressings being applied) 4. Within 10 minutes from arrival to recovery/intensive care unit 5. Just before discharge from recovery ward (or two hours post operatively if discharged directly from theatre to Neonatal Intensive Care/ Special Care Unit).
Secondary outcome [1] 432257 0
Measure the incidence of intra-operative and postoperative respiratory complications (apnoea, bradycardia, hypotension, desaturation, laryngospasm and bronchospasm) as a composite measure.
Timepoint [1] 432257 0
Intraoperative and the first 24 hours postoperatively.
Secondary outcome [2] 432258 0
Evaluate the feasibility of the use of EIT as respiratory monitoring in theatre setting
Timepoint [2] 432258 0
Assessed at intraoperative EIT recording time points
Secondary outcome [3] 441177 0
Evaluate the efficiency of the use of EIT as respiratory monitoring in theatre setting.
Timepoint [3] 441177 0
Assessed at intraoperative EIT recording time points

Eligibility
Key inclusion criteria
- Inguinal hernia surgery planned for either a general anaesthetic, spinal anaesthetic
or caudal, high flow nasal oxygen and sedation.
- Anaesthesia technique predetermined by treating team
-less than 64 weeks post menstrual age
Minimum age
No limit
Maximum age
64 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Mechanical ventilation immediately prior to procedure
- Parental or clinician refusal

Study design
Purpose
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is an observational descriptive study, the sample size is largely driven by what is logistically feasible and sufficient to allow for the patterns to be determined for more directed sample size calculations in future studies. Initially we wish to aim to recruit 20 - 30 subjects into each group.
Although the pattern of VT homogeneity is well described in the infant requiring ICU support, it is known to be highly variable and the pattern in healthy infants undergoing an anaesthetic is unknown. Consequently, primary analysis will be limited to simple descriptive statistics. The following would be considered a clinically meaningful change in each parameter:
CoV >2%
%VT in the dependent (or right) hemithorax >10%
Change in %atelectasis>5%
Depending on the frequency of inhomogeneity in either group we may choose to perform regression analysis to explore the association/correlation between risk factors and lung inhomogeneity. If the frequency is low, then there may be insufficient data for such an analysis. In this case we may consider recruiting more children to enable this analysis. This would only be after applying for a modification of ethics approval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/11/2024
Actual
Date of last participant enrolment
Anticipated
27/11/2026
Actual
Date of last data collection
Anticipated
27/11/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 315954 0
Charities/Societies/Foundations
Name [1] 315954 0
Flinders Foundation
Country [1] 315954 0
Australia
Funding source category [2] 317774 0
Charities/Societies/Foundations
Name [2] 317774 0
The Hospital Research Foundation Group
Country [2] 317774 0
Australia
Funding source category [3] 317775 0
Charities/Societies/Foundations
Name [3] 317775 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Country [3] 317775 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 318094 0
University
Name [1] 318094 0
Flinders University
Address [1] 318094 0
Country [1] 318094 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314782 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 314782 0
Ethics committee country [1] 314782 0
Australia
Date submitted for ethics approval [1] 314782 0
17/11/2023
Approval date [1] 314782 0
28/11/2023
Ethics approval number [1] 314782 0
2023/HRE00272

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132710 0
Dr Fiona Taverner
Address 132710 0
Flinders Medical Centre, Department of Anaesthesia, Flinders Drive, Bedford Park SA 5042
Country 132710 0
Australia
Phone 132710 0
+61 08 82046913
Fax 132710 0
Email 132710 0
[email protected]
Contact person for public queries
Name 132711 0
Fiona Taverner
Address 132711 0
Flinders Medical Centre, Department of Anaesthesia, Flinders Drive, Bedford Park SA 5042
Country 132711 0
Australia
Phone 132711 0
+61 08 82046913
Fax 132711 0
Email 132711 0
[email protected]
Contact person for scientific queries
Name 132712 0
Fiona Taverner
Address 132712 0
Flinders Medical Centre, Department of Anaesthesia, Flinders Drive, Bedford Park SA 5042
Country 132712 0
Australia
Phone 132712 0
+61 08 82046913
Fax 132712 0
Email 132712 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.