Condition category
Neonatal Diseases
Date applied
15/02/2018
Date assigned
15/05/2018
Last edited
27/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Malgorzata Warakomska

ORCID ID

Contact details

Broniewskiego 8a/2
Warsaw
01-785
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A5

Study information

Scientific title

Randomized evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU

Acronym

Study hypothesis

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

Ethics Committee Centre of Postgraduate Medical Education, 14/10/2015, ref: 77/PB/2015

Study design

Observational study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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 names

Primary outcome measures

The relative frequency and duration of audible alarms, collected with a datalogger plugged in to the ventilator throughout the study

Secondary outcome measures

The prevalence of SpO2 associated with hyperoxemia and hypoxemia, collected with a datalogger plugged in to the ventilator throughout the study

Overall trial start date

14/10/2015

Overall trial end date

15/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Infants with respiratory failure ventilated and with need of oxygen

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. 6 days of intervention
2. Clinical exacerbation
3. Weaned from AVEA-CLiO
4. Withdrawn consent

Recruitment start date

27/06/2016

Recruitment end date

15/07/2017

Locations

Countries of recruitment

Poland

Trial participating centre

Neonatology, Center of Medical Postgraduate Education
Czerniakowska 231
Warsaw
00-416
Poland

Sponsor information

Organisation

Neonatology, Independent Public Clinical Hospital of Prof W. Orlowski

Sponsor details

Czerniakowska 231
Warsaw
00-416
Poland

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes