Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12623000405617
Ethics application status
Approved
Date submitted
15/03/2023
Date registered
19/04/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
ECHIDNA: A study in infants having inguinal hernia repair surgery looking at their oxygen saturation levels before and after surgery using a Nonin oximeter
Scientific title
Evaluating Children undergoing inguinal Hernia surgery Investigating Desaturations using Nonin oximeter Assessments (ECHIDNA)
Secondary ID [1] 308841 0
None
Universal Trial Number (UTN)
Trial acronym
ECHIDNA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative Hypoxia 329160 0
Infants undergoing general anaesthesia 329161 0
Infants having inguinal hernia repair surgery 329162 0
Condition category
Condition code
Anaesthesiology 326134 326134 0 0
Anaesthetics
Oral and Gastrointestinal 326373 326373 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 326374 326374 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-centre pilot study will be carried out at Perth Children’s Hospital and King Edward Memorial Hospital in Western Australia. Participants will be recruited prior to the day of their surgery. Informed consent will be via eConsent in Redcap or via written paper versions of the parent information sheet and consent form. Once informed voluntary consent is obtained, the research team will provide the family with the Nonin WristOx pulse oximeter and consumables (batteries, fixomull, sensor) for the child to wear for 48 continuous hours prior to inguinal hernia repair surgery. Parents will be provided with an instruction sheet on how to apply the device and troubleshoot common problems. If the patient is a current inpatient at Perth Children’s Hospital or in the neonatal intensive care unit at King Edward Memorial Hospital, then the Nonin WristOx pulse oximeter and consumables will be provided to the nursing staff and will be worn in addition to the normal ward monitoring. If the participant is an inpatient at Perth Children’s Hospital prior to their surgery, transcutaneous carbon dioxide (tcCO2) monitoring will be applied using the SenTec digital monitoring device and tcCO2 data will be collected for 12 hours pre-operatively as a baseline.

Blood Oxygen levels (SpO2) will be measured by the Nonin wrist-worn oximeter device (WristOx 3150, Nonin Medical, Plymouth, MN) for 48 hours pre- and post the operation. The Nonin WristOx 3150 is a small, lightweight pulse oximeter that can be placed on the side of the cot, with the probe applied to the infants’ toe or foot. This type of device can be used in hospital and at the patient’s home as it is easy to use and is activated when the probe is connected. To assess the whole ventilatory profile, transcutaneous carbon dioxide levels (tcCO2) will be measured by the non-invasive digital monitoring system, SenTec (SenTec, Lincoln, RI 02685 United States).

On the day of surgery, all children will be anaesthetised in accordance with the Australian New Zealand College of Anaesthetists safety standards. Relevant information on the patient's demographics, medical history and perioperative management will be collected. Once returned to the ward, all children will have tcCO2 monitoring postoperatively, a probe will be applied to the patient’s forehead or shoulder on the first night after surgery. The tcCO2 device will record for a maximum of 12 hours overnight and will be connected to the patient within an hour of their normal bedtime. Oximetry data will be obtained using the same Nonin oximeter. These post-operative measurements will be performed in addition to standard ward monitoring. Patient's will wear the Nonin WristOx 3150 for 48 continuous hours and it will be connected to the patient once they reach the post operative ward or ICU.

Intervention code [1] 325535 0
Diagnosis / Prognosis
Comparator / control treatment
A pilot study without control group or randomisation
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333998 0
Recruitment rate for the study upon review of screening and recruitment logs.
Timepoint [1] 333998 0
From start of recruitment screening to end of study recruitment period.
Primary outcome [2] 333999 0
Rate of adherence to the protocol without deviation as assessed by review of the study data and medical records.
Timepoint [2] 333999 0
From patient enrolment until end of participation
Primary outcome [3] 334000 0
To assess the feasibility of obtaining oximetry measurements from infants pre- and post- operatively from review of all evaluable data downloaded from the equipment. The definition of evaluable data is at least 4 hours of continuous good quality monitoring data.
Timepoint [3] 334000 0
From the start of recording time to the end of the 48 hours for each patient. Data will be collected for 48 hours pre-operatively and 48 hours post-operatively.
Secondary outcome [1] 419039 0
Acceptability of Nonin monitoring device to the ward nursing staff as queried on study specific questionnaire.
Timepoint [1] 419039 0
Monthly from the beginning of study until end of recruitment period.
Secondary outcome [2] 419040 0
To compare infants’ oximetry profile before and after inguinal hernia repair surgery using Nonin portable oximetry by examining the oxygen desaturation index (ODI3), the mean recorded spO2 levels, T90 (Length of wear time for which SpO2 < 90%), T90% (Percentage of wear time for which SpO2 < 90%) and average heart rate.
Timepoint [2] 419040 0
Oximetry measurements will commence 48 hours prior to surgery and continue from surgery to 48 hours post-hernia repair.
Secondary outcome [3] 419041 0
To investigate infant’s transcutaneous carbon dioxide levels the night of inguinal hernia repair surgery using the SenTec device
Timepoint [3] 419041 0
All patient's will have 12 hours of transcutaneous carbon dioxide monitoring on the night following their post-hernia repair.
Secondary outcome [4] 419042 0
Incidence of desaturations and apnoeas before inguinal hernia repair by reviewing Nonin oximetry report, SenTec report (if available) and medical records
Timepoint [4] 419042 0
From start of data collection to end of analysis
Secondary outcome [5] 419916 0
To investigate infant’s transcutaneous carbon dioxide levels the night of inguinal hernia repair surgery using the SenTec device +/- preoperative. This will be investigated by looking at the average tcCO2 measurements, the tcCO2 measurements, and any evidence of hypoventilation measured by time for which tcCO2 > 50 mmHg for more than 25% of the total sleep or wear time
Timepoint [5] 419916 0
If the patient is a current inpatient at Perth Children's Hospital, transcutaneous carbon dioxide measurements will be recorded for 12 hours the night before surgery. In addition, all patient's will have 12 hours of transcutaneous carbon dioxide monitoring on the night following their post-hernia repair.
Secondary outcome [6] 420999 0
Incidence of desaturations and apnoeas after inguinal hernia repair by reviewing Nonin oximetry report, SenTec report (if available) and medical records
Timepoint [6] 420999 0
From start of data collection to end of analysis
Secondary outcome [7] 421000 0
Measure of oxygen desaturation index with a 3% SpO2 drop (ODI3) before and after surgery. Measured as number of events with 3% SpO2 drop per hour retrieved from the Nonin report from the Nonin WristOx watch.
Timepoint [7] 421000 0
Nonin WristOx measurements will commence 48 hours prior to surgery and continue from surgery to 48 hours post-hernia repair.
Secondary outcome [8] 421001 0
Measure of oxygen saturation (SpO2) as recorded by the Nonin WristOx watch
Timepoint [8] 421001 0
Nonin WristOx measurements will commence 48 hours prior to surgery and continue from surgery to 48 hours post-hernia repair.
Secondary outcome [9] 421002 0
The measure of time (percentage and minutes) that the oxygen saturation (SpO2) was less than 90% as measured and recorded by the Nonin WristOx watch.
Timepoint [9] 421002 0
Nonin WristOx measurements will commence 48 hours prior to surgery and continue from surgery to 48 hours post-hernia repair.
Secondary outcome [10] 421003 0
Measure of average transcutaneous carbon dioxide (TcCO2) on the night of surgery recorded and measured by the SenTec device
Timepoint [10] 421003 0
Patient's will have 12 hours of transcutaneous carbon dioxide monitoring on the night following their post-hernia repair.
Secondary outcome [11] 421004 0
Measure of maximum transcutaneous carbon dioxide (TcCO2) recorded and measured by the SenTec device
Timepoint [11] 421004 0
Patient's will have 12 hours of transcutaneous carbon dioxide monitoring on the night following their post-hernia repair.
Secondary outcome [12] 421005 0
Evidence of hypoventilation will be assessed by the values of SpO2 and TcCO2 measured and recorded through the SenTec device
Timepoint [12] 421005 0
Patient's will have 12 hours of transcutaneous carbon dioxide monitoring on the night following their post-hernia repair.
Secondary outcome [13] 421006 0
Measure of heart rate will be recorded through both the Nonin WristOx and SenTec device
Timepoint [13] 421006 0
Nonin WristOx measurements will commence 48 hours prior to surgery and continue from surgery to 48 hours post-hernia repair. Patient's will also have 12 hours of transcutaneous carbon dioxide monitoring on the night following their post-hernia repair.

Eligibility
Key inclusion criteria
Infants up to 6 months corrected gestational age.
Undergoing elective inguinal hernia repair under general anaesthesia and/or regional block
Minimum age
1 Weeks
Maximum age
10 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Infants with known airway abnormalities or neurological conditions
• Infants with known significant cardiopulmonary disease
• Inability to give informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Multi-centre, pilot study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be conducted in the R statistical environment, and statistical significance will be taken at 5% (0.05). Data will be explored using graphical and numeric summaries. To assess the feasibility objectives, the proportion of successful enrolments out of the total number of potential patients approached, and the proportion of protocol deviations or violations out of the number of enrolled participants will both be reported. Rates of missingness for Nonin oximetry and SenTec measurements will also be reported, as well as the proportion of enrolled participants with complete datasets.

To assess the secondary objectives relating to the Nonin oximeter measurements, linear statistical models will be fitted to the Nonin variables (ODI3, mean SpO2, T90 min, T90 percent, and mean heart rate) as outcomes, with covariates including measurement timepoint (two measurements pre-surgery and two post-surgery), patient characteristics and surgical details. This model will allow us to quantify any change in oximeter measurements post-surgery, as well as establish whether any patient characteristics are risk-factors for altered oximetry measurements post-surgery. Graphical representations of the oximetry data will also be explored.

To investigate the infants’ transcutaneous CO2 levels on the night of surgery, SenTec measurements (mean TCO2, maximum TCO2, evidence of hypoventilation) will be summarised using graphical and numeric summaries. If enough infants have baseline pre-surgery SenTec measurements, a linear statistical model will be fit to the data with the change in SenTec measurement pre- to post-surgery as the outcome, and the baseline pre-surgery measurement entered as a moderator. Demographic and surgical details will be included as covariates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
26/05/2023
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
7/05/2025
Actual
Sample size
Target
60
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24146 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 24147 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 39658 0
6009 - Nedlands
Recruitment postcode(s) [2] 39659 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 313066 0
Hospital
Name [1] 313066 0
Perth Children's Hospital
Country [1] 313066 0
Australia
Funding source category [2] 313407 0
Government body
Name [2] 313407 0
NHMRC
Country [2] 313407 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 315173 0
None
Name [1] 315173 0
Address [1] 315173 0
Country [1] 315173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312317 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 312317 0
Child and Adolescent Health Service Human Research Ethics Committee
15 Hospital Avenue
Nedlands
Western Australia 6009
Ethics committee country [1] 312317 0
Australia
Date submitted for ethics approval [1] 312317 0
16/01/2023
Approval date [1] 312317 0
27/02/2023
Ethics approval number [1] 312317 0
RGS0000005692

Summary
Brief summary
Surgical repair of an inguinal hernia is a common procedure in early childhood. The incidence of inguinal hernia’s is inversely related to an infant’s birth weight, gestational age, and is more common in boys. Prematurity (less than 36 weeks gestational age) is identified as a major risk factor for the development of inguinal hernias, with approximately 30% of preterm infants diagnosed with an inguinal hernia. Most preterm infants diagnosed with inguinal hernias in our institution will undergo surgical repair prior to discharge from the neonatal intensive care unit (NICU). It is well documented that preterm infants undergoing general anaesthesia have an increased risk of cardiorespiratory events including apnoea and bradycardia.
Respiratory adverse events are common in paediatric anaesthesia and comprise more than three quarters of all critical incidents and half of all unplanned admission to paediatric intensive care unit.
While studies have looked at the post-operative apnoeas and the risk associated with apnoea in infants, there are few studies that have explored the respiratory trajectory of these patients undergoing inguinal hernia repairs.

In this study, oximetry and apnoeas will be measured both pre- and post-operatively, along with transcutaneous carbon dioxide levels on the night of surgery to investigate the impact of anaesthesia and surgery on these young infants.
Particularly, identifying infants at increased risk of respiratory complications through pre-operative continuous pulse oximetry may potentially reduce morbidity and help guide clinicians on the optimal allocation of resources including the length and intensity of post-operative monitoring required, and ultimately the anaesthesia management plan.

This is a pilot study to assess the feasibility of investigating the respiratory profile (deviation from baseline SpO2, desaturation events, apnoeas, carbon dioxide levels) in infants (up to 6 months corrected age) undergoing inguinal hernia repair to assess the recovery profile after surgery under general anaesthesia and/ or regional block at Perth Children’s Hospital, a tertiary specialist paediatric centre to inform the planning of a larger trial. The study will also evaluate the rate of participant recruitment and rate of adherence to the protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124226 0
Prof Britta Regli-von Ungern Sternberg
Address 124226 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 124226 0
Australia
Phone 124226 0
+61 420790101
Fax 124226 0
Email 124226 0
[email protected]
Contact person for public queries
Name 124227 0
Britta Regli-von Ungern-Sternberg
Address 124227 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 124227 0
Australia
Phone 124227 0
+61 420790101
Fax 124227 0
Email 124227 0
[email protected]
Contact person for scientific queries
Name 124228 0
Britta Regli-von Ungern-Sternberg
Address 124228 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 124228 0
Australia
Phone 124228 0
+61 420790101
Fax 124228 0
Email 124228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Investigators for the study have not yet decided on data sharing.


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.