Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622161
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Automated Oxygen Control in Preterm Babies on Respiratory Support A Randomized Cross Over Study
Status:
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:
None
Brief Summary:
Babies admitted in the NICU neonatal intensive care unit frequently need supplemental oxygen to keep their oxygen saturation SpO2 in target range TR Hypoxia and hyperoxia episodes should be avoided while working toward this goal Preterm babies are particularly vulnerable to abnormal oxygen levels and adverse effects of hyperoxia and oxygen toxicity may result in retinopathy of prematurity and bronchopulmonary dysplasia Similarly mortality may rise due to hypoxic events In routine practice the SpO2 target is usually achieved by manual adjustment of FiO2 fraction of inspired oxygen but it usually does not accomplish the desired SpO2 target leading to episodes of hyperoxia and hypoxia and increased risk of complications A study was conducted in multiple centers involving extremely preterm babies the results of which depicted that the babies on manual control of FiO2 spent only 48 of their time with SpO2 in the target range 16 below the target range and 36 above it The compliance of the SpO2 target range was also variable in these centers There is a need to improve compliance by using automated oxygen control systems
At the Aga Khan University Hospital AKUH investigators have included SLE 6000 SLE Croydon UK ventilators in their NICU neonatal intensive care unit which have automated oxygen control device Oxygenie that continuously adjusts FiO2 fraction of inspired oxygen of the patient to keep SpO2 in the target range avoiding abnormal oxygen levels This also reduces the workload on staff and improves patient care Investigators usually put preterm babies on these ventilators so that SpO2 can be kept most of the time in the target range When the OxyGenie and SpO2 monitoring are added to the SLE 6000 ventilator it becomes possible to accurately regulate and deliver closed loop oxygen to preterm infants This automated oxygen control system limits episodes of both hypoxia and hyperoxia by using the VDL 11 algorithm that uses an adaptive Proportional-Integral-Derivative PID algorithm to control the FiO2 adjustments in response to changes in SpO2 This keeps SpO2 within a target range TR which user selects A randomized crossover trial comparing two devices for automated oxygen control in preterm infants included the SLE 6000 ventilator as one of its devices
At the Aga Khan University Hospital AKUH investigators have included SLE 6000 SLE Croydon UK ventilators in their NICU neonatal intensive care unit which have automated oxygen control device Oxygenie that continuously adjusts FiO2 fraction of inspired oxygen of the patient to keep SpO2 in the target range avoiding abnormal oxygen levels This also reduces the workload on staff and improves patient care Investigators usually put preterm babies on these ventilators so that SpO2 can be kept most of the time in the target range When the OxyGenie and SpO2 monitoring are added to the SLE 6000 ventilator it becomes possible to accurately regulate and deliver closed loop oxygen to preterm infants This automated oxygen control system limits episodes of both hypoxia and hyperoxia by using the VDL 11 algorithm that uses an adaptive Proportional-Integral-Derivative PID algorithm to control the FiO2 adjustments in response to changes in SpO2 This keeps SpO2 within a target range TR which user selects A randomized crossover trial comparing two devices for automated oxygen control in preterm infants included the SLE 6000 ventilator as one of its devices
Detailed Description:
Investigators will conduct a radomized cross-over trial 24 Preterm babies will be sampled and to account for attrition 26 preterm babies will be enrolled Preterm babies born at less than 37 weeks of gestation will be included in the study For each of the twelve-hour periods they will be randomized to either manually controlled oxygen or automated oxygen control After 12-hour periods they will be shifted to alternate interventions The total duration will be 24 hours Written consent will be obtained from the parentguardian before recruitment
Block randomization will be done to randomize the babies SLE 6000 ventilators will be used and settings will be adjusted by the clinical team as per the clinical condition of the baby
The Radical neonatal pulse oximeter Masimo is used to automatically adjust FiO2 in order to maintain SpO2 within a designated target range Before turning on oxygen FiO2 is manually adjusted to achieve SpO2 in the target range Once stable SpO2 is achieved in TR oxygen is turned on which then adjusts FiO2 to keep SpO2 within target range The FiO2 changes and their frequency are determined by the SpO2 trend whether the SpO2 is above below or within the target range and all changes are proportionate to the baseline FiO2 level The pulse oximeters settings will include normal sensitivity an average time of 2-4 seconds a 20-second alarm delay and an alarm limit of 89 and 95 SpO2 Whenever feasible the right wrist is used to apply the Masimo neonatal probe The user will be advised on screen if the SpO2 signal will be lost Oxygenie would display in blue waiting for a signal and would remain on the current FiO2 value for the first 60 seconds After this point if the SpO2 is within TR it will continue at the current FiO2 level If the SpO2 is above the TR and the FiO2 is 10 above the reference range it will slowly decrease to the reference value If SpO2 is below TR and FiO2 is more than 5 below the reference FiO2 then it will slowly increase to the reference level The reference FiO2 value is updated every 30 minutes and is based on the last 60-minute average
Block randomization will be done to randomize the babies SLE 6000 ventilators will be used and settings will be adjusted by the clinical team as per the clinical condition of the baby
The Radical neonatal pulse oximeter Masimo is used to automatically adjust FiO2 in order to maintain SpO2 within a designated target range Before turning on oxygen FiO2 is manually adjusted to achieve SpO2 in the target range Once stable SpO2 is achieved in TR oxygen is turned on which then adjusts FiO2 to keep SpO2 within target range The FiO2 changes and their frequency are determined by the SpO2 trend whether the SpO2 is above below or within the target range and all changes are proportionate to the baseline FiO2 level The pulse oximeters settings will include normal sensitivity an average time of 2-4 seconds a 20-second alarm delay and an alarm limit of 89 and 95 SpO2 Whenever feasible the right wrist is used to apply the Masimo neonatal probe The user will be advised on screen if the SpO2 signal will be lost Oxygenie would display in blue waiting for a signal and would remain on the current FiO2 value for the first 60 seconds After this point if the SpO2 is within TR it will continue at the current FiO2 level If the SpO2 is above the TR and the FiO2 is 10 above the reference range it will slowly decrease to the reference value If SpO2 is below TR and FiO2 is more than 5 below the reference FiO2 then it will slowly increase to the reference level The reference FiO2 value is updated every 30 minutes and is based on the last 60-minute average
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