Application of opaque wrap for improving pulse oximeter sensitivity in neonates: a randomised controlled trial

ISRCTN ISRCTN10302534
DOI https://doi.org/10.1186/ISRCTN10302534
Secondary identifying numbers CH-OPUS-Version 16
Submission date
25/03/2018
Registration date
15/04/2018
Last edited
23/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Oxygen is carried in the blood attached to hemoglobin molecules. Oxygen saturation is a measure of how much oxygen the blood is carrying as a percentage of the maximum it could carry. Oxygen saturation can be measured non-invasively using pulse oximetry. The pulse oximeter probe is often covered with an opaque wrap, as environmental or phototherapy light could interfere with the oxygen saturation measurement. The aim of this study is to find out whether covering the pulse oximeter sensor with an opaque wrap will provide a more accurate reading and faster result.

Who can participate?
Infants in the neonatal intensive care unit or postnatal ward of University Hospital of North Tees

What does the study involve?
Infants are randomly allocated to undergo pulse oximeter recording using a sensor either with or without an opaque wrap. They then switch over to the other type of sensor for another recording. This data is not be used for treatment - a separate pulse oximeter is used if needed.

What are the possible benefits and risks of participating?
There won’t be any direct benefit to participants, but this study will help to improve the understanding of oxygen saturation measurements in newborns. Since this study doesn’t involve any invasive procedures there won’t be any discomfort /risk of participating.

Where is the study run from?
University Hospital of North Tees (UK)

When is the study starting and how long is it expected to run for?
January 2018 to March 2019

Who is funding the study?
Local R&D incentive funding

Who is the main contact?
Dr Prakash Loganathan

Contact information

Dr Prakash Kannan Loganathan
Scientific

University Hospital of North Tees
Hardwick Rd, Hardwick
Stockton-On-Tees
TS19 8PE
United Kingdom

ORCiD logoORCID ID 0000-0003-3717-8569

Study information

Study designInterventional single-center randomised controlled trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please contact details to request a participant information sheet
Scientific titleOpaque wrap for PUlse oximeter Sensor in neonates
Study acronymOPUS
Study objectivesApplication of opaque wrap to pulse oximeter sensor (OWPS) obtains faster results (saturation, heart rate) when compared to sensor application without any opaque wrap (PS) in ambient light and phototherapy.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNeonatal oxygen saturation monitoring
InterventionThere will be two stratum (groups) based on gestation: >27 weeks to 34 weeks; >34 weeks. This will help in having a sufficient number of small babies and validate the data in small babies. Recruitment will start after 24hrs to allow sufficient time for transition, until their hospital stay. Random numbers will be created using online tool by one of the research team member who is not involved in recruitment. The sequence will be generated and stored in an opaque-sealed envelope. This envelope will be opened after parent's consent, at the time of recruitment. Blinding is not feasible due to the nature of the intervention, but all the pulse oximeter recordings will be blinded. Moreover, downloaded data doesn't contain any information regarding the intervention received.

1. Opaque wrap with pulse oximeter sensor (OWPS)
2. Pulse oximeter sensor without any opaque wrap (PS)

Each infant after the initial intervention (OWPS or PS) based on randomization will cross over to the other intervention subsequently for another period of 10 minutes. For example, if an infant is initially randomized to OWPS, the trialists will perform pulse oximeter recording with opaque wrap for a period of 10 minutes, following which the same infant will undergo another 10 minutes of pulse oximeter recording without opaque wrap. The subsequent intervention will be carried out after restarting the pulse oximeter machine and the sensor will be applied on the same foot. The advantage of this method is that the same infant could act as own control, to compare the two techniques in the same infant. Both Nellcor and Masimo recording will be carried out simultaneously in both feet, so each infant will undergo total of 20 minutes of recording.

All the study recordings will happen during the daytime and with hospital/intensive care/ambient light or phototherapy. The data from the research pulse oximeters will not be used for any clinical management; a separate pulse oximeter from the neonatal unit attached to wrist (right/left) will be used for all the clinical management, if needed. These recordings will be done when the infant is quiet/sleep state. This recording will occur under the direct supervision of one of the investigators. Medical team/parents will be able to carry out routine activities, if needed.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureThe time to display a valid data for the two techniques (pulse oximeter sensor with opaque wrap versus pulse oximeter sensor without opaque wrap). Total duration of recording will be for 10 minutes from the time of valid data display. Valid data as per study protocol definition. These data will be downloaded directly from both monitors into research laptop
Secondary outcome measures1. Number of valid data points for the two techniques (OWPS and PS) during the 10 minute recording will be compared from the downloaded data
2. Number of artifacts for the two techniques (OWPS and PS) during the 10 minute recording will be compared from the downloaded data. Artifacts as per study protocol definition
Overall study start date01/01/2018
Completion date31/08/2019

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants100
Total final enrolment117
Key inclusion criteria1. All infants ≥27 weeks of gestation
2. Neonates admitted in neonatal intensive care unit or postnatal ward
3. A parent or guardian is able and willing to provide informed consent
Key exclusion criteria1. Antenatal or postnatal diagnosed major congenital malformations (e.g. congenital diaphragmatic hernia, congenital heart disease, hydrops, lung malformation and known blood dyscrasias)
2. Neonates who are undergoing therapeutic hypothermia, as hypothermia could interfere in pulse oximeter sensitivity
3. Critically ill Infants based on the discretion on medical team
Date of first enrolment01/06/2018
Date of final enrolment30/01/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospital of North Tees
Hardwick Rd
Hardwick
Stockton on Tees
TS19 8PE
United Kingdom

Sponsor information

North Tees and Hartlepool Hospitals NHS Foundation Trust
Hospital/treatment centre

Research and development office
1st floor, Middlefield Centre
Stockton on Tees
TS19 8PE
England
United Kingdom

ROR logo "ROR" https://ror.org/04zzrht05

Funders

Funder type

Other

Local R&D incentive funding

No information available

Results and Publications

Intention to publish date31/03/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planStudy protocol including other documents will be available on request. Planned publication of the study results in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from the research and development office (researchanddevelopment@nth.nhs.uk). All de-identified/anonymised data will be available after trial completion after formal request and approval by the local R & D department. This is already included in the patient consent form and participant information leaflet.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2021 23/11/2020 Yes No

Editorial Notes

23/11/2020: Publication reference added.
16/01/2020: Internal review.
04/04/2019: The following changes have been made:
1. The recruitment end date was changed from 31/03/2019 to 30/01/2019.
2. The total final enrolment was added.
10/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 01/12/2018 to 31/03/2019.
2. The overall trial end date has been updated from 31/03/2019 to 31/08/2019.