Dataset Information

Evaluation of Sibel's Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya.

ABSTRACT:

Background

Neonatal multiparameter continuous physiological monitoring (MCPM) technologies assist with early detection of preventable and treatable causes of neonatal mortality. Evaluating accuracy of novel MCPM technologies is critical for their appropriate use and adoption.

Methods

We prospectively compared the accuracy of Sibel's Advanced Neonatal Epidermal (ANNE) technology with Masimo's Rad-97 pulse CO-oximeter with capnography and Spengler's Tempo Easy reference technologies during four evaluation rounds. We compared accuracy of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and skin temperature using Bland-Altman plots and root-mean-square deviation analyses (RMSD). Sibel's ANNE algorithms were optimized between each round. We created Clarke error grids with zones of 20% to aid with clinical interpretation of HR and RR results.

Results

Between November 2019 and August 2020 we collected 320 hours of data from 84 neonates. In the final round, Sibel's ANNE technology demonstrated a normalized bias of 0% for HR and 3.1% for RR, and a non-normalized bias of -0.3% for SpO2 and 0.2°C for temperature. The normalized spread between 95% upper and lower limits-of-agreement (LOA) was 4.7% for HR and 29.3% for RR. RMSD for SpO2 was 1.9% and 1.5°C for temperature. Agreement between Sibel's ANNE technology and the reference technologies met the a priori-defined thresholds for 95% spread of LOA and RMSD. Clarke error grids showed that all HR and RR observations were within a 20% difference.

Conclusion

Our findings suggest acceptable agreement between Sibel's ANNE and reference technologies. Clinical effectiveness, feasibility, usability, acceptability, and cost-effectiveness investigations are necessary for large-scale implementation.

SUBMITTER: Coleman J

PROVIDER: S-EPMC9246120 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Clinically feasible multiparameter continuous physiological monitoring technologies are needed for use in resource-constrained African healthcare facilities to allow for early detection of critical events and timely intervention for major morbidities in high-risk neonates. We conducted a prospective clinical feasibility study of a novel multiparameter continuous physiological monitoring technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of Sibel's Advanced Neonatal Epidermal (ANNE) technology to reference technologies, including Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2) measurements and Spengler's Tempo Easy non-contact infrared thermometer for temperature measurements. We evaluated key performance criteria such as up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies in an uncontrolled, real-world setting. Between September 15 and December 15, 2020, we collected and analyzed 503 h of ANNE data from 109 enrolled neonates. ANNE's up-time was 42 (11%) h more for HR, 77 (25%) h more for RR, and 6 (2%) h less for SpO2 compared to the Rad-97. However, ANNE's ratio of up-time to total attached time was less than Rad-97's for HR (0.79 vs 0.86), RR (0.68 vs. 0.79), and SpO2 (0.69 vs 0.86). ANNE demonstrated adequate performance in identifying high and low HR and RR and high temperature events; however, showed relatively poor performance for low SpO2 events. The normalized spread of limits of agreement were 8.4% for HR and 52.2% for RR and the normalized root-mean-square deviation was 4.4% for SpO2. Temperature agreement showed a spread of limits of agreement of 2.8 °C. The a priori-identified optimal limits were met for HR and temperature but not for RR or SpO2. ANNE was clinically feasible for HR and temperature but not RR and SpO2 as demonstrated by the technology's up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies.

Project description:ObjectiveTo assess the feasibility, usability and acceptability of two non-invasive, multiparameter, continuous physiological monitoring (MCPM) technologies for use in neonates within a resource-constrained healthcare setting in sub-Saharan Africa.DesignA qualitative study using in-depth interviews and direct observations to describe healthcare professional and caregiver perspectives and experiences with investigational MCPM technologies from EarlySense and Sibel compared with selected reference technologies.SettingPumwani Maternity Hospital is a public, high-volume, tertiary hospital in Nairobi, Kenya.ParticipantsIn-depth interviews were conducted with five healthcare administrators, 12 healthcare providers and 10 caregivers. Direct observations were made of healthcare providers using the technologies on 12 neonates overall.ResultsDesign factors like non-invasiveness, portability, ease-of-use and ability to measure multiple vital signs concurrently emerged as key themes supporting the usability and acceptability of the investigational technologies. However, respondents also reported feasibility challenges to implementation, including overcrowding in the neonatal unit, lack of reliable access to electricity and computers, and concerns about cost and maintenance needs. To improve acceptability, respondents highlighted the need for adequate staffing to appropriately engage caregivers and dispel misconceptions about the technologies.ConclusionStudy participants were positive about the usefulness of the investigational technologies to strengthen clinical care quality and identification of at-risk neonates for better access to timely interventions. These technologies have the potential to improve equity of access to appropriate healthcare services and neonatal outcomes in sub-Saharan African healthcare facilities. However, health system strengthening is also critical to support sustainable uptake of technologies into routine care.Trial registration numberNCT03920761.

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