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ID
Source
Brief title
Health condition
Neonatal respiratory insufficiency
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency of hypoxic episodes (SpO2 <80% for 1 second or longer)
Secondary outcome
Time SpO2 spent in allocated target range, or above when set FiO2 <0.22.
Time SpO2 spent under 91%.
Time SpO2 spent in range 91%-96%, or above when set FiO2 <0.22.
Time SpO2 spent above 96% when set FiO2 >0.21.
Coefficient of variation of SpO2.
Time in hypoxaemic SpO2 ranges (SpO2 85%-90%, 80-84%, <80%).
Time in hyperoxaemic SpO2 ranges (SpO2 97%-98%, >98%) when set FiO2 >0.21.
Duration of hypoxaemic episodes (SpO2 <85% and <80%).
Frequency of hypoxaemic episodes (SpO2 <85% and <80%) for ≥30 seconds and ≥60 seconds.
Duration of hyperoxaemic episodes (SpO2 >96% and >98%) when set FiO2 >0.21.
Frequency of hyperoxaemic episodes (SpO2 >96% and >98%) for ≥30 seconds and ≥60 seconds when set FiO2 >0.21.
Frequency of bradycardic episodes (HR <100 bpm for ≥10 seconds).
Average oxygen exposure (average measured FiO2)
Coefficient of variation of FiO2
Frequency of SpO2 alarms on smartphone
Total duration of SpO2 alarms on smartphone
Background summary
A randomised crossover study comparing the effect of two oxygen saturation target ranges on time spent under the target range while preterm infants are on automated oxygen control. We will investigate whether
Hypoxia and hyperoxia during oxygen therapy for preterm infants can result in significant morbidity and mortality. To reduce these risks, continuous measurement of oxygen saturation (SpO2) guides the titration of supplemental oxygen to target SpO2 values of 91-95%. We have previously studied the effect of two automated oxygen controllers (the OxyGenie and the CLiO2) on time spent within a set target range in the COCkPIT trial. We showed a distinct difference in the distribution of oxygen saturation between controllers: the OxyGenie controller had a narrower distribution, with a significant reduction in time above target range when compared to the CLiO2 controller. However, this was accompanied by a disproportionally smaller increase in time spent under target range (15% during Oxygenie control, 9% during CLiO2 control). These differences may partly be explained by the tendency for the OxyGenie controller to target the midpoint of the target range (93% in case of a target range of 91%-95%). In contrast the CLiO2 controller, according to its patent, targets a SpO2 value of 94% while in target range. Considering the non-linearity of the oxygen tension and oxygen saturation relation (oxygen dissociation curve), it is possible that aiming for a higher target range while using automated oxygen titration will result in less time spent under the target range and fewer target range deviations.
Study objective
We postulate that a set target range of 92%-96% will result in a more stable SpO2 and accompanying reduction of time spent with an SpO2 <91% and similar or less time >96% when compared to a target range of 91%-95%.
Study design
Outcome parameters (SpO2, FiO2, HR, frequency and duration of alarms) will continuously be monitored at a frequency of 1Hz by the standard bedside monitoring (Philips MP70) system throughout the two days of study participation.
Intervention
Interventional target range: OxyGenie automated oxygen controller set to target an SpO2 of 92%-96% for 25 hours, including a 1 hour wash-out period after a change in set target range.
Standard target range: OxyGenie automated oxygen controller set to target an SpO2 of 91%-95% for 24 hours, excluding a 1 hour wash-out period after a change in set target range.
Inclusion criteria
• Born between 24 weeks 0 days and 31 weeks and 6 days gestation.
• Receiving respiratory support (mechanical ventilation, HFO, NCPAP, NIPPV, or HFNC).
• Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrolment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
• Expected to complete the 49-hour study period in the current form of respiratory support.
• A postnatal age of less than 36 weeks.
• Written informed parental consent.
Exclusion criteria
• Major congenital anomalies
• Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrolment.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9662 |
| Other | METC Leiden Den Haag Delft : P21.038 |