Randomized evaluation of two SpO2 alarm strategies during ventilation with automated oxygen supply control in the NICU
| ISRCTN | ISRCTN49239883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49239883 |
| Protocol serial number | A5 |
| Sponsor | Neonatology, Independent Public Clinical Hospital of Prof W. Orlowski |
| Funder | Investigator initiated and funded |
- Submission date
- 15/02/2018
- Registration date
- 15/05/2018
- Last edited
- 08/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
When infants in the neonatal intensive care unit require ventilation and oxygen supplementation, their oxygen levels are monitored by pulse oximetry (SpO2). In most Polish units, SpO2 alarms are set tightly with a relatively short alarm delay. This approach ensures that nurses are alerted to the possible need for an adjustment or other action. Centers setting their alarms loosely experience less frequent persistent alarms. This approach seems to be good as it reduces the number of false alarms and thus alarm fatigue. The aim of this study is to find out whether a loose alarm strategy reduces SpO2 alarm frequency without increasing over reliance on automation and increasing exposure to SpO2 extremes.
Who can participate?
Infants with respiratory (breathing) failure who are being ventilated and are in need of oxygen
What does the study involve?
Two oxygenation alarm strategies are used. The tight strategy sets the SpO2 alarms to trigger just outside the target range with a 30-second delay. The loose strategy sets the threshold wider with a 90-second delay. Infants are switched between the two strategies every 24 hours until the infant is stabilized and is placed on Infant Flow or for a total of up to 6 days, whichever is first. The relative frequency and duration of audible alarms are collected with a datalogger plugged in to the ventilator throughout the study.
What are the possible benefits and risks of participating?
The loose strategy may reduce the risk associated with alarm fatigue and make it easier to keep the infant in the target oxygenation range.
Where is the study run from?
Neonatology, Center of Medical Postgraduate Education (Poland)
When is the study starting and how long is it expected to run for?
October 2015 to July 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Małgorzata Warakomska
Contact information
Scientific
Broniewskiego 8a/2
Warsaw
01-785
Poland
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | Randomized evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU |
| Study objectives | The paradigm of setting SpO2 alarms during automated control ought to be different than during periods of manual control. In most Polish units, SpO2 alarms are set tightly with a relatively short alarm delay. This approach is typical during manual control to insure the nurses are alerted to the possible need for an FiO2 adjustment or other action. We currently use the same strategy when using CLiO2, as do many other centers. Our recent review of the Polish CLiO2 Use Registry determined that those centers setting their alarms loosely experienced less “frequent persistent” alarms. This approach seems to be good as it reduces the number of false alarms and thus alarm fatigue. |
| Ethics approval(s) | Ethics Committee Centre of Postgraduate Medical Education, 14/10/2015, ref: 77/PB/2015 |
| Health condition(s) or problem(s) studied | Newborn babies with respiratory failure ventilated in NICU with AVEA CLiO2 ventilator |
| Intervention | The study will compare two oxygenation alarm strategies, starting on the first day of life and ending with a transition in respiratory support or at 6 days, whichever occurred first. The tight strategy (TAS) set the SpO2 alarms to trigger just outside the target range, with a 30-second delay. The loose strategy (LAS) set the threshold wider with a 90-second delay. The SpO2 target range setting on the A-FiO2 system was selected by the attending physician, with a nominal range of 88-95%. The study will enroll 20 subjects who need for oxygen and will cross over between these strategies every 24 hours until the infant is stabilized and is placed on Infant Flow or for a total of up to 6 days, whichever is first. The initial and daily changes to alarm settings were implemented by the research team. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
The relative frequency and duration of audible alarms, collected with a datalogger plugged in to the ventilator throughout the study |
| Key secondary outcome measure(s) |
The prevalence of SpO2 associated with hyperoxemia and hypoxemia, collected with a datalogger plugged in to the ventilator throughout the study |
| Completion date | 15/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 26 |
| Key inclusion criteria | Infants with respiratory failure ventilated and with need of oxygen |
| Key exclusion criteria | 1. 6 days of intervention 2. Clinical exacerbation 3. Weaned from AVEA-CLiO 4. Withdrawn consent |
| Date of first enrolment | 27/06/2016 |
| Date of final enrolment | 15/07/2017 |
Locations
Countries of recruitment
- Poland
Study participating centre
Warsaw
00-416
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/05/2019 | 08/05/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/05/2019: Total final enrolment and publication reference were added.
