A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit
Condition: Neonatal Disease
MeSH terms: Infant, Newborn, Diseases
Study type: Interventional

Summary: 
      On the neonatal unit in Derby, two types of probes are in routine use: Mindray 520 N and
      Mindray 521 N. Feedback from parents and staff show that there are concerns that the two
      probes given very different oxygen saturation readings and, often, do not agree with each
      other. This has raised concerns that infants' clinical care may be affected by the choice of
      probe. It is important to know if the two probes give similar results or not to ensure that
      infants get the appropriate monitoring and respiratory support as needed for good neonatal
      care. In this study, we will compare the reading made by the two probes and determine whether
      the readings of the two probes agree with each other and if any disagreement is such that
      clinical decision making is affected by the difference.
    

Detailed description: 
      Continuous monitoring of oxygen saturation level is a key component of neonatal intensive
      care and NICE recommends that all neonatal services "ensure that systems are in place for
      preterm babies to have a target saturation level of 91% to 95%" and that this is monitored
      using "continuous pulse oximetry" (NICE Quality statement 4 in Quality Standard QS193:
      https://www.nice.org.uk/guidance/qs193/chapter/Quality-statement-4-Oxygen-saturation). Oxygen
      saturation monitoring is used to provide optimal respiratory support to preterm infants to
      ensure adequate oxygenation of tissues while preventing risks of conditions such as
      retinopathy of prematurity and bronchopulmonary dysplasia [1]. It is equally important in
      term born infants who require intensive care such as for determining adequate oxygenation for
      respiratory support and screening for congenital heart disease [2]. For these reasons, most
      infants in neonatal units are continuously monitored using pulse oximetry, a simple and
      painless test that measures blood oxygen levels by passing a small beam of light through the
      infant's hand or foot. This measures the changes in light absorption to calculate the levels
      of oxygenated and deoxygenated blood. To do this the light (or probe) has to be attached to
      the infant's hand or foot using a tie or a sticker. The probe must be attached firmly for the
      saturation monitor to pick up the correct readings. As neonatal skin is delicate and it is
      often difficult to stick objects to it, neonatal oxygen saturation probes are carefully
      designed. Many different types of saturation probes are in routine use in neonatal units. It
      is important to ensure that they give accurate and comparable readings. In the neonatal unit
      in Derby, two types of probes are in routine use: Mindray 520 N and Mindray 521 N. Feedback
      from parents and staff show that there are concerns that the two probes given very different
      oxygen saturation readings and, often, do not agree with each other. This has raised concerns
      that infants' clinical care may be affected by the choice of probe. It is important to know
      if the two probes give similar results or not to ensure that infants get the appropriate
      monitoring and respiratory support as needed for good neonatal care. In this study, we will
      compare the reading made by the two probes and determine whether the readings of the two
      probes agree with each other and if any disagreement is such that clinical decision making is
      affected by the difference.
    

Intervention name(s): Oxygen saturation probe Mindray 520 N and Mindray 521 N
Intervention type(s): Device
Intervention description(s): Two oxygen saturation probes will be used in this study:
Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin.
Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group, randomised study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic