To determine the accuracy of the *NeoBeat* device against gold standard measurements obtained by an ECG monitor with disposable (gel) electrodes and against pulse measured preductally as derived by pulse-oximeter.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation of all pulse rate measurements of the Neobeat, ECG monitor and
pulse oximetry device:
All continuous data will be compared during the first 10 minutes after birth.
The relationship between the three devices will be evaluated using Bland-Altman
bias analysis; the difference between the measurements will be plotted against
their average. The sensitivity, specificity, positive predictive values, and
negative predictive values of measurements collected using the Neobeat, ECG and
pulse oximetry for detecting HRECG <100 bpm will be calculated.
Secondary outcome
1) Correlation between signals of the three monitoring devices over time.
All continuous data will be compared during the first 10 minutes after birth.
Data will be plotted over time and averaged for 30 second intervals and plotted
for each different monitoring device. Data will be compared using an Anova for
multiple continuous normally distributed values
2) Duration from application until a reliable signal is acquired.
The time until the first reliable signal is acquired is averaged for all three
devices and compared using an ANOVA for normally distributed values. The
Friedmans* test will be used for non-normally distributed data.
Background summary
The majority of neonates undergo neonatal transition at birth without any
problems, however around 5% of term infants and 60% of preterm infants receive
some form of respiratory support. According to international guidelines, the
necessity for support during neonatal resuscitation is assessed using 2
objectively measured parameters: heart rate and oxygen saturation. The
evaluation of the clinical condition of the infant depends on accurate
measurement of heart rate. According to the guidelines positive pressure
ventilation should be commenced below a heart rate of 100 beats per minute and
below 60 beats per minute chest compressions should be commenced.
Heart rate can be measured either by clinically assessing pulse, but this is
unreliable. Other more reliable methods are measuring pulse on one of the
extremities using a pulse oximeter or by using electrocardiography (ECG) to
measure the electrical activity of the heart. The overall difference between
pulse measured by ECG and pulse measured by pulse-oximetry (PO) is small (only
4 beats difference on average). However, at the start of transition shortly
after birth measurement differences can be up to 35 beats per minute, which
could lead to unnecessary interventions.
ECG measurements are the golden standard for heart rate measurements in adults
and neonates. They are fast and will provide a reliable measurement within 2
seconds after application. *Neobeat*, is a novel arch-shaped device for
measuring heart rate during neonatal resuscitation using dry-electrode ECG. It
can quick and easily be applied by placing it around the abdomen or thorax of
the neonate and does not need any disposable electrodes, making it ideal for
low-resource settings. Only one study has proven that the Neobeat is a fast and
safe device to use during transition. There is no data available in which it
has been compared with other devices which are commonly used to measure heart
rate.
With this study we would like to investigate the accuracy of this device by
determining 1) correlation of all pulse rate measurements of the *Neobeat*,
standard ECG monitor and pulse-oximeter. 2) Correlation between signals of the
three monitoring devices over time. 3) Duration from application of the
*NeoBeat* until a reliable signal is acquired.
Study objective
To determine the accuracy of the *NeoBeat* device against gold standard
measurements obtained by an ECG monitor with disposable (gel) electrodes and
against pulse measured preductally as derived by pulse-oximeter.
Study design
A prospective observational study.
Study burden and risks
Burden for patients:
Measuring of vital parameters (using ECG and PO) at birth is a standard
procedure and will always be used when deemed necessary by the caregiver during
transition at birth. The *NeoBeat* is a device which fits around the thorax of
an infant and does not hamper neonatal transition as it will not obstruct
breathing. Although chest compressions could still be administered when the
device is present the device will be removed if chest compressions are
necessary to make sure it does not interfere with treatment.
Risks and benefits:
Both benefits and risks are limitedThere are no benefits or risks in this study
as newborn infants are included and regular monitoring is used according to
(inter)national guidelines and no clinical decisions will be based upon the
extra data collected using the *Neobeat* device.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Infants born at a gestational age at least 32 weeks who are evaluated on the
resuscitation table during neonatal transition at birth. The estimated birth
weight must be at least 1500 grams
Exclusion criteria
Infants that have congenital abnormalities of the thorax, an estimated foetal
weight of less than 1500 grams, or are withheld life support at birth
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL71052.058.19 |