A Study of Agreement Between Oxygen Saturation Measured by Two Probes in Infants on the Neonatal Unit

NCT ID: NCT05065229

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2023-01-14

Brief 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.

Conditions

Neonatal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

A

Right foot no.520 Left foot no.521

Group Type: EXPERIMENTAL

Oxygen saturation probe Mindray 520 N and Mindray 521 N

Intervention Type: DEVICE

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.

B

Right foot no.521 Left foot no.520

Group Type: EXPERIMENTAL

Oxygen saturation probe Mindray 520 N and Mindray 521 N

Intervention Type: DEVICE

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.

Interventions

Oxygen saturation probe Mindray 520 N and Mindray 521 N

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Infants who need oxygen saturation monitoring for clinical care
• Infants born preterm (<37 weeks' gestation) who are < 7 days of age and need respiratory support including supplemental oxygen
• Infants born preterm (<37 weeks' gestation) who are in supplemental oxygen at >34 weeks' gestation
• Infants born at term gestation (< 37 weeks' gestation) who require respiratory support including supplemental oxygen
• Infants with suspected cardiac disease

Exclusion Criteria

• Infants who have intravenous or arterial lines attached to either foot.
• Infants who have any condition that may cause differential oxygen saturation or blood flow to the lower limbs such as venous thrombosis.
• Infants who have local infections or skin lesions on either foot.
• Infants older than 5 months of age

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 60 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

shalini ojha

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University Hospitals of Derby and Burton

Derby, Derbyshire, United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS 297715

Identifier Type: -

Identifier Source: org_study_id