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Trial registered on ANZCTR


Registration number
ACTRN12623000379617
Ethics application status
Approved
Date submitted
13/03/2023
Date registered
14/04/2023
Date last updated
4/08/2023
Date data sharing statement initially provided
14/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study measuring Oxygen and Carbon Dioxide in order to assess the impact of Opiate Infusions on young children Undergoing Palatoplasties
Scientific title
Investigating Oximetry and Capnography To assess the impact of Opiate Infusions on Patients Undergoing Palatoplasties – a Pilot Study (OCTOPUS)
Secondary ID [1] 308842 0
None
Universal Trial Number (UTN)
Trial acronym
OCTOPUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children undergoing palatoplasty surgery
 329090 0
Children receiving opiate infusions 329091 0
Children undergoing general anaesthesia 329338 0
Condition category
Condition code
Anaesthesiology 326067 326067 0 0
Anaesthetics
Oral and Gastrointestinal 326393 326393 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 326394 326394 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single-centre pilot study will be carried out at Perth Children’s Hospital in Western Australia. Once voluntary informed consent is obtained, the participant will be issued with a Nonin WristOx pulse oximeter, and all required batteries and fixumol tape, for the participant to wear for at least 8 hours on three consecutive nights, along with a diary to record the times for which the device was worn. The Nonin WristOx 3150 is a small, lightweight pulse oximeter designed to be worn comfortably on the patient’s wrist or ankle and is ideal for use in the patient’s home (WristOx 3150, Nonin Medical, Plymouth, MN). Pre-operative monitoring will be completed within 8 weeks of the patient’s surgery date.

On the day of surgery relevant information on the patient’s demographics and medical history will be collected. Parents will be asked to complete a brief questionnaire on their child’s sleeping habits pre-operatively. Continuous monitoring of oxygen will commence within an hour of the patient being connected to their post-operative opiate infusion. Oximetry data will be obtained using the same Nonin WristOx 3150. Transcutaneous CO2 (tcCO2) will be measured overnight using the SenTec digital monitoring system (SenTec, Lincoln, RI 02685 United States) using a probe connected to the patient’s forehead or shoulder. TcCO2 sensors will be connected within two hours of the patient’s normal bedtime, on the night of surgery. Both sensors will be removed 12 hours after the tcCO2 sensor is placed. These post-operative measurements will be performed in addition to standard ward monitoring.
Intervention code [1] 325476 0
Diagnosis / Prognosis
Comparator / control treatment
A pilot feasability study without a control group or randomisation. Patients will recieve standard ward monitoring which includes the Phillips Intellivue oxygen saturation monitor with pulse oximeter additional oximetry monitoring. Patients will additionally receive monitoring via a Nonin WristOx 3150 and capnography monitoring via the SenTec digital monitoring system.
Control group
Active

Outcomes
Primary outcome [1] 333927 0
To assess the rate of successful participant recruitment as determined by an audit of study screening logs and enrollment logs at the completion of recruitment.
Timepoint [1] 333927 0
From beginning of study until end of recruitment.
Primary outcome [2] 333928 0
To assess the rate of adherence to the protocol without deviation as determined by a review of the medical records.
Timepoint [2] 333928 0
From participant enrollement until end of participation.
Primary outcome [3] 333936 0
To assess the viability of the assessment of overnight oxygenation and ventilation in infants post-palatoplasty from review of all evaluable data from the equipment. Evaluable data is defined as a minimum of 4 hours of good quality monitoring data.
Timepoint [3] 333936 0
The quality of the measurements will be assessed following every patient until the recruitment target is met.
Secondary outcome [1] 418769 0
To evaluate oxygenation in infants following cleft palate repair.
Timepoint [1] 418769 0
During measurements taken on the first night following palatoplasty. Oximetry measurements taken using the Nonin WristOx 3150 will commence within an hour of the patient being connected to their post-operative opiate infusion. Sensor will be removed the following morning.
Secondary outcome [2] 418770 0
To compare standard ward monitoring and continuous oximetry and capnography monitoring for their ability to identify opiate induced ventilatory impairment. Oximetry will be monitored by the Nonin WristOx 3150 and capnography will be measured by the SenTec digital monitoring system. Standard ward monitoring includes the Phillips Intellivue oxygen saturation monitor with pulse oximeter.
Timepoint [2] 418770 0
During measurements taken on the first night following palatoplasty. Oximetry measurements taken with the Nonin WristOx 3150 will commence within an hour of the patient being connected to their post-operative opiate infusion. The SenTec carbon dioxide sensor will be connected within two hours of the patient’s normal bedtime. Both sensors will be removed 12 hours after the carbon dioxide sensor is placed.
Secondary outcome [3] 418771 0
Acceptability of study procedures to ward clinical staff as determined by survey of involved clinical staff designed specifically for this study.
Timepoint [3] 418771 0
Weekly from beginning of study until end of recruitment.
Secondary outcome [4] 419513 0
To evaluate ventilation in infants following cleft palate repair.
Timepoint [4] 419513 0
During measurements taken on the first night following palatoplasty. Carbon dioxide sensors (Sentec) will be connected within two hours of the patient’s normal bedtime. The sensor will be removed after 12 hours.
Secondary outcome [5] 420654 0
To collect data on the opioid dose given to patients following palatoplasty by review of medical records.
Timepoint [5] 420654 0
For the time from end of anaesthesia to hospital discharge.

Eligibility
Key inclusion criteria
Patients aged 0 to 18 months undergoing cleft palate repair under general anaesthesia who will be receiving a post-operative opiate infusion.
Minimum age
No limit
Maximum age
18 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with known significant cardiopulmonary disease.
Children currently taking opioid medications.
Children going intubated to the HDU/ICU post-operatively.
Children who will be unable to complete at-home oximetry pre-operatively.
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The oxygen and CO2 levels of patients will be graphed with respect to time to investigate any patterns. These measurements will also be graphed against the opioid dosage over time so the effect of opioid administration can be investigated.

Linear mixed-effects statistical models will be fitted to oxygen levels and CO2 levels against opioid dosages, demographic and other available variables. Various correlation and variance structures will also be investigated.
Another important aspect of such data is the prevalence of missing values. Suitable imputation techniques will be used to mitigate the effect of missing data.

Statistical significance will be assessed at 5% (0.05), and all analysis will be conducted in the R statistical environment.

Sample size:
This is a pilot study, and no previous similar data is available. Between 40 to 50 such surgeries are performed at PCH annually. Of these we expect to recruit around 30 per year. For this pilot study we will recruit 60 patients. Since no previous data is available, statistical power calculations are problematic. However, we will calculate post-hoc power based on the study data. This data will inform a larger multi-centre trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
18/07/2023
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
2/04/2025
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24079 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 39588 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 313067 0
Hospital
Name [1] 313067 0
Perth Children's Hospital
Country [1] 313067 0
Australia
Funding source category [2] 313245 0
Government body
Name [2] 313245 0
NHMRC
Country [2] 313245 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] 314973 0
None
Name [1] 314973 0
Address [1] 314973 0
Country [1] 314973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312318 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 312318 0
Child and Adolescent Health Service Human Research Ethics Committee
15 Hospital Avenue
Nedlands
Western Australia 6009
Ethics committee country [1] 312318 0
Australia
Date submitted for ethics approval [1] 312318 0
16/01/2023
Approval date [1] 312318 0
16/02/2023
Ethics approval number [1] 312318 0
RGS0000005886

Summary
Brief summary
Cleft palate is a birth defect that affects the roof of the mouth and requires surgery in the first year of life to close the abnormal opening between the nose and mouth. After surgery, moderate to severe pain is managed using opioid painkillers. However, opioids can cause breathing problems and can be especially risky for children who have had cleft palate surgery.

Monitoring a patient's oxygen and carbon dioxide levels can help clinicians understand a patient's respiratory status and detect changes in their breathing and ventilation. This is important in patients who are vulnerable to breathing problems, such as patients recovering after cleft palate surgery. Carbon dioxide monitoring is not currently a routine feature of monitoring for palatoplasty patients.

A proposed pilot study aims to monitor both oxygen and carbon dioxide saturations in infants on opioid infusions after palatoplasty to better understand their ventilatory recovery after cleft palate surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124230 0
Prof Britta Regli-von Ungern-Sternberg
Address 124230 0
Perth Children's Hospital
Department of Anaesthesia and Pain Medicine
15 Hospital Avenue
Nedlands
WA 6009
Country 124230 0
Australia
Phone 124230 0
+61 8 64564805
Fax 124230 0
Email 124230 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for public queries
Name 124231 0
Prof Britta Regli-von Ungern-Sternberg
Address 124231 0
Perth Children's Hospital
Department of Anaesthesia and Pain Medicine
15 Hospital Avenue
Nedlands
WA 6009
Country 124231 0
Australia
Phone 124231 0
+61 8 64564805
Fax 124231 0
Email 124231 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 124232 0
Prof Britta Regli-von Ungern-Sternberg
Address 124232 0
Perth Children's Hospital
Department of Anaesthesia and Pain Medicine
15 Hospital Avenue
Nedlands
WA 6009
Country 124232 0
Australia
Phone 124232 0
+61 8 64564805
Fax 124232 0
Email 124232 0
Britta.Regli-VonUngern@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
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.