To test the safety and feasibility of a closed loop controller of the FiO2 based on the measured SpO2 in a NICU setting.
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter during the study is the time the SpO2 spend within the
target range.
Secondary outcome
Secondary outcomes are the number of hyper and hypoxic events, average maximum
and minimum SpO2 during these events, number of FiO2 adjustments (manual and
automated) and cerebral oxygen saturation.
Background summary
Supplemental oxygen is given to preterm infants to ensure that they have an
adequate arterial saturation (SpO2). Fluctuations in the SpO2 mean that the
fraction of inspired oxygen (FiO2) needs to be adjusted, a challenging and time
consuming task. During the recovery of a desaturation there is often an
overshoot, resulting in a period of hyperoxia. Hyperoxia interferes with
vascular development of the lungs and eyes, and there is growing evidence that
hyperoxia may be equally damaging to the developing brain.
An observational study conducted on our Neonatal Intensive Care Unit (NICU) has
shown that infants on average spend only 54% of the time within the SpO2 limits
and 71 adjustments to the FiO2 are made each day.
An automated controller (PRICO) has been developed that adjusts the FiO2 based
on the SpO2. A study in a preterm lamb model has shown the effectiveness of
this closed loop controller: less periods of desaturation and hyperoxia were
demonstrated.
Study objective
To test the safety and feasibility of a closed loop controller of the FiO2
based on the measured SpO2 in a NICU setting.
Study design
Neonates that are included will start with an 8 hour block of manual adjustment
of the FiO2. After completion of this block they will be switched to the
automated control of the FiO2 for another 8 hours. After that they are switched
back for another 8 hours of manual control, which is used to correct for any
changes of the state of the neonate during the trial. For each ventilation type
(high frequency , invasive and non-invasive) 24 patients will be included.
Intervention
Automated control of the FiO2 based on the measured SpO2 during 8 hours.
Study burden and risks
There is no burden to the patient, and the risk is minimal. The same patient
monitoring is used during the study as during routine care. The closed loop
algorithm is implemented in to the Acutronic Fabian HFO ventilator, so that no
additional equipment is needed at the bedside.
The controller is designed so that it checks the input signals, the validity of
the pulse oximetry and the quality of the ventilation. If any of the checked
parameters is not within the specified limits the controller will not adjust
the FiO2 and give an alarm.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Neonates who require respiratory support and supplemental oxygen therapy
Exclusion criteria
Planned dismissal or transfer to a other hospital within 24 hours
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51887.000.16 |