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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal Ventilation

Lung Homogeneity

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Respiratory

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At the conclusion of anaesthesia.

Secondary outcome [1]

Correlation between incidence of postoperative respiratory complications (observed from anaesthesia monitor) and presence of ventilation inhomogeneity (assessed by EIT and Florian monitor).

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia and Pain Management, The Royal Children's Hospital

Address [1]

Department of Anaesthesia and Pain Management The Royal Children's Hospital Flemington Road Parkville VIC 3052

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

The Royal Children's Hospital 
Flemington Road
Parkville
VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/01/2016

Approval date [1]

28/01/2016

Ethics approval number [1]

36008A

Summary

Brief summary

Mechanical ventilation is often required to support respiratory function but it can cause lung injury. This risk is well understood in the Intensive Care Unit setting where mechanical ventilation is often required for long periods of time but the impact of short exposure to mechanical ventilation during anaesthesia is unknown. Some populations, in particular neonates and small infants, are at greater risk of this potential detrimental effect. One of the principal factors related to ventilator induced lung injury is the inhomogeneity of lung ventilation. To evaluate lung homogeneity, imaging techniques are usually used, although these are often invasive, intermittent and time consuming. Recently a new technology, called Electrical Impedance Tomography (EIT), has been developed. 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. This study will use EIT to define the patterns of tidal ventilation within the chest and determine whether mechanical ventilation during general anaesthesia increases the risk of lung inhomogeneity in neonates and small infants. We also hope to determine if there is a correlation between the degree of lung inhomogeneity and different aspects of mechanical ventilation. These results could improve our knowledge about the impact of mechanical ventilation on the neonatal lung and help us to find best management for neonatal ventilation during an anaesthetic.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bae Corlette

Address

The Royal Children's Hospital Flemington Road Parkville VIC 3052

Country

Australia

Phone

+61 3 9345 4901

Fax

[email protected]

Contact person for public queries

Name

Bae Corlette

Address

The Royal Children's Hospital Flemington Road Parkville VIC 3052

Country

Australia

Phone

+61 3 9345 4901

Fax

[email protected]

Contact person for scientific queries

Name

Bae Corlette

Address

The Royal Children's Hospital Flemington Road Parkville VIC 3052

Country

Australia

Phone

+61 3 9345 4901

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Interested parties with projects where the PI agree that the data set would be used appropriately.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Entire database (de-identified data only)

What types of analyses could be done with individual participant data?

• Any purpose for which the PI agrees that the data set would be used appropriately.

When can requests for individual participant data be made (start and end dates)?

From:
December 2022. No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Dr Bae Corlette: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email
10892	Study protocol	[email protected]
10893	Informed consent form	[email protected]
10894	Ethical 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.

Trial Review

Documents added manually

Documents added automatically