Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000818437
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
22/06/2016
Date last updated
24/02/2022
Date data sharing statement initially provided
4/03/2021
Date results provided
24/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring breathing in children during anaesthesia: The Electrical Impedance Tomography study
Scientific title
Assessment of lung homogeneity with Electrical Impedance Tomography (EIT) in neonates and small infants during mechanical ventilation in theatre:
a prospective observational cohort study
Secondary ID [1] 289474 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Ventilation 299155 0
Lung Homogeneity 299156 0
Condition category
Condition code
Anaesthesiology 299175 299175 0 0
Other anaesthesiology
Respiratory 299176 299176 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will place the electrical impedance tomography (EIT) belt around the participant's chest. We will record EIT measurements for 2 minutes pre-anaesthesia, for 2 minutes at the start of anaesthesia and for 2 minutes at 30 minute intervals until the end of anaesthesia and 2 minutes post-anaesthesia. Patients are followed up until they are discharged from the recovery unit.
Intervention code [1] 295057 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298658 0
The primary outcome is the tidal volume homogeneity (VT homogeneity) which is calculated using several variables:
- CoV >2%
- %VT in the dependent (or right) hemithorax >10%
- Change in %atelectasis >5%
- VT >2mL/kg
- Cdyn >0.1mL/kg/cmH2O

This outcome is assessed using EIT and the Florian monitor.
Timepoint [1] 298658 0
At the conclusion of anaesthesia.
Secondary outcome [1] 324860 0
Correlation between incidence of postoperative respiratory complications (observed from anaesthesia monitor) and presence of ventilation inhomogeneity (assessed by EIT and Florian monitor).
Timepoint [1] 324860 0
At the conclusion of anaesthesia.

Eligibility
Key inclusion criteria
1. Neonates and small infants aged less than or equal to 1 year of age
2. Children scheduled for general anaesthesia that requires endotracheal intubation with a cuffed tube
3. Children scheduled for procedures that require them to be in a supine position
Minimum age
No limit
Maximum age
1 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Children in whom the placement of EIT belt at the standard position (nipple level) would interfere with surgical care: for example cardiac and thoracic surgery
2. Children with known pulmonary disease
3. Children who have previously been mechanically ventilated
4. Children with <32 weeks completed gestational age at birth

Study design
Purpose
Screening
Duration
Cross-sectional
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 for recruiting 30 subjects.
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% VT >2mL/kg
Cdyn >0.1mL/kg/cmH2O
Depending on the frequency of inhomogeneity 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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Already had sufficient data
Date of first participant enrolment
Anticipated
Actual
31/03/2016
Date of last participant enrolment
Anticipated
31/05/2021
Actual
1/05/2018
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
40
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5991 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 13413 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 293836 0
Hospital
Name [1] 293836 0
Department of Anaesthesia and Pain Management, The Royal Children's Hospital
Country [1] 293836 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
The Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 292671 0
None
Name [1] 292671 0
Address [1] 292671 0
Country [1] 292671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295264 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 295264 0
Ethics committee country [1] 295264 0
Australia
Date submitted for ethics approval [1] 295264 0
07/01/2016
Approval date [1] 295264 0
28/01/2016
Ethics approval number [1] 295264 0
36008A

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

Contacts
Principal investigator
Name 51702 0
Dr Bae Corlette
Address 51702 0
The Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 51702 0
Australia
Phone 51702 0
+61 3 9345 4901
Fax 51702 0
Email 51702 0
[email protected]
Contact person for public queries
Name 51703 0
Bae Corlette
Address 51703 0
The Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 51703 0
Australia
Phone 51703 0
+61 3 9345 4901
Fax 51703 0
Email 51703 0
[email protected]
Contact person for scientific queries
Name 51704 0
Bae Corlette
Address 51704 0
The Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 51704 0
Australia
Phone 51704 0
+61 3 9345 4901
Fax 51704 0
Email 51704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Entire database (de-identified data only)
When will data be available (start and end dates)?
December 2022. No end date determined.
Available to whom?
Interested parties with projects where the PI agree that the data set would be used appropriately.
Available for what types of analyses?
Any purpose for which the PI agrees that the data set would be used appropriately.
How or where can data be obtained?
Dr Bae Corlette: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10892Study protocol  [email protected]
10893Informed consent form  [email protected]
10894Ethical approval  [email protected]



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.