SurePulse VS MFT Evaluation

• Research type

  Research Study

• Full title

  SurePulse VS Evaluation (Manchester University NHS Foundation Trust)

• IRAS ID

  288541

• Contact name

  J Carpenter

• Contact email

  james@surepulsemedical.com

• Sponsor organisation

  SurePulse Medical Limited

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  SurePulse VS is a heart rate monitoring system specifically designed for newborn babies. SurePulse VS received CE approval as a Class IIb medical device in 2019 under the EU Medical Device Directive. The new Medical Device Regulations process requires that approved devices need to undertake formal Post-Marketing Clinical Follow-up (PMCF) for continued product development, risk management and quality assurance. There is therefore a need to measure the SurePulse VS user-friendliness and effectiveness with feedback from healthcare professionals and, importantly, parents.

  The evaluation will deploy the CE-approved VS heart rate monitor in 100 newborn babies, alongside existing standard monitoring. Clinician and staff feedback will be sought on the utility of SurePulse VS device in Neonatal and Maternity units, and 20-40 mothers will be engaged to give feedback through a simple questionnaire.

  SurePulse Medical Ltd has previously sought feedback from clinical staff through product development and the insights gained led to several product enhancements. A User Summative Evaluation was conducted at NUH and a formative User Evaluation was conducted at the University of Birmingham Womens and Children Hospital. Parental feedback (NICU) was also obtained during pre-market clinical investigations (IRAS 187149; ClinicalTrials.gov Identifier: NCT02701920). Parental feedback has not yet been prospectively sought from parents of babies born through caesarean section or in the labour suites.

  SurePulse Medical Ltd therefore now seeks further staff feedback:
  a) To ascertain clinical advantage(s) of using SurePulse VS newborn heart rate monitor
  b) To evaluate the effectiveness of the training programme in supporting healthcare professional use

  In addition further parental feedback is sought to support:
  a) Continued product development (for example the look, feel and comfort of the Cap) and ongoing risk management
  b) Acceptability of the device in the Delivery Room and other locations (for example the utility that wireless heart rate monitoring delivers in facilitating early parental-baby direct contact and bonding)

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  21/PR/0293

• Date of REC Opinion

  20 May 2021

• REC opinion

  Further Information Favourable Opinion