Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515080
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Predicting Outcomes Using Infra-red SEnsors a Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Physiological Monitoring in the OR Predicting Outcomes Using Infra-red SEnsors a Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PORPOISE-F
Brief Summary:
The aim of this study is to investigate if it is feasible to use a protocol in which avoiding oxygen desaturation in the brain during general anaesthesia can reduce the risk of negative postoperative behavior changes in children
We will recruit children from at least five centres around the world for this feasibility study Brain oxygenation will be monitored with Near Red Infrascopy NIRS which is like a saturation monitor placed on the forehead of the child during anesthesia The anesthesia is done as per routine but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain We will also ask the parents to fill in a questionnaire with 25 questions about changes in their childs behavior 7 days after the operation
We will recruit children from at least five centres around the world for this feasibility study Brain oxygenation will be monitored with Near Red Infrascopy NIRS which is like a saturation monitor placed on the forehead of the child during anesthesia The anesthesia is done as per routine but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain We will also ask the parents to fill in a questionnaire with 25 questions about changes in their childs behavior 7 days after the operation
Detailed Description:
This project will investigate the potential effect of a protocol targeted at counteracting cerebral desaturation during anaesthesia with the aim of reducing negative post-operative changes in children Negative post-operative changes NPOBC represent a surrogate outcome for neurocognitive damage associated with hemodynamic changes during general anaesthesia This is a feasibility study that will examine anaesthesia teams reactions to changes in 1 regional cerebral oxygen saturation crSO2 2 systemic hypotension or hypoxaemia while also reporting any technical issues with data acquisition We will also estimate the incidence of negative post-operative changes and explore any association with reduced crSO2 in our patient population compared with previous international data Specifically this feasibility study will provide data for the robust design and power analysis of a large-scale randomised interventional trial in children undergoing anaesthesia with the utilisation of a protocol targeting cerebral oxygen desaturation vs a control group of standard care with no access to crSO2 monitoring
Methods At least 500 children of ages 6 months - 59 months will be recruited from at least 5 centers around the world Besides routine monitoring cerebral regional oxygen saturation crsO2 will be monitored throughout the procedure
Primary outcome The primary outcome is the feasibility of successful data collection of crO2 physiological and PHBQ data in a larger population over multiple international sites This includes the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting will be determined
Secondary outcomes
The incidence of reduced crSO2 below baseline more than 10
The area under the curve AUC of reduced crSO2 below baseline
The incidence of negative postoperative behaviour changes as determined by the PHBQ administered on day 7 30 following surgery
A set of threshold values for and form of interventions to restore cr02 andor mean arterial blood pressure Actions may include any of the following interventions fluid bolus vasoactive agents Trendelenburg position adjustment of anaesthetic dose and change of ventilation settings
The incidence of negative post-operative behavioural change and the extent of any association with the AUC of crSO2 below baseline
Methods At least 500 children of ages 6 months - 59 months will be recruited from at least 5 centers around the world Besides routine monitoring cerebral regional oxygen saturation crsO2 will be monitored throughout the procedure
Primary outcome The primary outcome is the feasibility of successful data collection of crO2 physiological and PHBQ data in a larger population over multiple international sites This includes the incidence of technical problems with NIRS monitoring and the parental noncompliance with PHBQ reporting will be determined
Secondary outcomes
The incidence of reduced crSO2 below baseline more than 10
The area under the curve AUC of reduced crSO2 below baseline
The incidence of negative postoperative behaviour changes as determined by the PHBQ administered on day 7 30 following surgery
A set of threshold values for and form of interventions to restore cr02 andor mean arterial blood pressure Actions may include any of the following interventions fluid bolus vasoactive agents Trendelenburg position adjustment of anaesthetic dose and change of ventilation settings
The incidence of negative post-operative behavioural change and the extent of any association with the AUC of crSO2 below baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None