Dataset Information

Comparison of Heart Rate Feedback from Dry-Electrode ECG, 3-Lead ECG, and Pulse Oximetry during Newborn Resuscitation.

ABSTRACT: Assessment of heart rate (HR) is essential during newborn resuscitation, and comparison of dry-electrode ECG technology to standard monitoring by 3-lead ECG and Pulse Oximetry (PO) is lacking. NeoBeat, ECG, and PO were applied to newborns resuscitated at birth. Resuscitations were video recorded, and HR was registered every second. Device placement time from birth was median (quartiles) 6 (4, 18) seconds for NeoBeat versus 138 (97, 181) seconds for ECG and 152 (103, 216) seconds for PO. Time to first HR presentation from birth was 22 (13, 45) seconds for NeoBeat versus 171 (129, 239) seconds for ECG and 270 (185, 357) seconds for PO. Proportion of time with HR feedback from NeoBeat during resuscitation from birth was 85 (69, 93)%, from arrival at the resuscitation table 98 (85, 100)%, and during positive pressure ventilation 100 (95, 100)%. For ECG, these proportions were, 25 (0, 43)%, 28 (0, 56)%, and 33 (0, 66)% and for PO, 0 (0, 16)%, 0 (0, 16)%, and 0 (0, 18)%. All p < 0.0001. NeoBeat was faster to place, presented HR more rapidly, and provided feedback on HR for a larger proportion of time during ongoing resuscitation compared to 3-lead ECG and PO.

SUBMITTER: Rettedal S

PROVIDER: S-EPMC8700180 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Comparison of Heart Rate Feedback from Dry-Electrode ECG, 3-Lead ECG, and Pulse Oximetry during Newborn Resuscitation.

Rettedal Siren S Eilevstjønn Joar J Kibsgaard Amalie A Kvaløy Jan Terje JT Ersdal Hege H

Children (Basel, Switzerland) 20211126 12

<h4>Background</h4>Assessment of heart rate (HR) is essential during newborn resuscitation, and comparison of dry-electrode ECG technology to standard monitoring by 3-lead ECG and Pulse Oximetry (PO) is lacking.<h4>Methods</h4>NeoBeat, ECG, and PO were applied to newborns resuscitated at birth. Resuscitations were video recorded, and HR was registered every second.<h4>Results</h4>Device placement time from birth was median (quartiles) 6 (4, 18) seconds for NeoBeat versus 138 (97, 181) seconds fo ...[more]

PMID: 34943288

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Project description:Introduction3%-8% of newborns need positive pressure ventilation (PPV) after birth. Heart rate (HR) is considered the most sensitive indicator of the newborns' condition and response to resuscitative interventions. According to guidelines, HR should be assessed and PPV initiated within 60 s after birth in non-breathing newborns. Dry electrode ECG can provide accurate feedback on HR immediately after birth and continuously during resuscitation. The impact of early and continuous HR feedback is unknown.Method and analysisThis single-centre randomised controlled trial seeks to determine if HR feedback by dry electrode ECG immediately after birth and continuously during newborn resuscitation results in more timely initiation of PPV, improved ventilation and short-term outcomes compared with standard HR assessment.In all newborns≥34 gestational weeks, the dry electrode ECG sensor is placed on the upper abdomen immediately after birth as an additional modality of HR assessment. The device records and stores HR signals. In intervention subjects, the HR display is visible to guide decision-making and further management, in control subjects the display is masked. Standard HR assessment is by stethoscope, gel-electrode ECG and/or pulse oximetry (PO).Time of birth is registered in the Liveborn app. Time of initiation and duration of PPV is calculated from video recordings. Ventilation parameters are retrieved from the ventilation monitor, oxygen saturation and HR from the PO and gel-electrode ECG monitors.The primary endpoint is proportion of resuscitated newborns who receive PPV within 60 s after birth. To detect a 50% increase with power of 90% using an overall significance level of 0.05 and 1 interim analysis, 169 newborns are needed in each group.Ethics and disseminationApproval by the Norwegian National Research Ethics Committee West (2018/338). Parental consent is sought at routine screening early in pregnancy. The results will be published in peer-reviewed journal and presented at conferences.Trial registration numberNCT03849781.

Project description:BackgroundPhotoplethysmography (PPG) is a technology routinely used in clinical practice to assess blood oxygenation (SpO2) and pulse rate (PR). Skin pigmentation may influence accuracy, leading to health outcomes disparities.ObjectiveThis systematic review and meta-analysis primarily aimed to evaluate the accuracy of PPG-derived SpO2 and PR by skin pigmentation. Secondarily, we aimed to evaluate statistical biases and the clinical relevance of PPG-derived SpO2 and PR according to skin pigmentation.MethodsWe identified 23 pulse oximetry studies (n=59,684; 197,353 paired SpO2-arterial blood observations) and 4 wearable PR studies (n=176; 140,771 paired PPG-electrocardiography observations). We evaluated accuracy according to skin pigmentation group by comparing SpO2 accuracy root-mean-square values to the regulatory threshold of 3% and PR 95% limits of agreement values to +5 or -5 beats per minute (bpm), according to the standards of the American National Standards Institute, Association for the Advancement of Medical Instrumentation, and the International Electrotechnical Commission. We evaluated biases and clinical relevance using mean bias and 95% CI.ResultsFor SpO2, accuracy root-mean-square values were 3.96%, 4.71%, and 4.15%, and pooled mean biases were 0.70% (95% CI 0.17%-1.22%), 0.27% (95% CI -0.64% to 1.19%), and 1.27% (95% CI 0.58%-1.95%) for light, medium, and dark pigmentation, respectively. For PR, 95% limits of agreement values were from -16.02 to 13.54, from -18.62 to 16.84, and from -33.69 to 32.54, and pooled mean biases were -1.24 (95% CI -5.31 to 2.83) bpm, -0.89 (95% CI -3.70 to 1.93) bpm, and -0.57 (95% CI -9.44 to 8.29) bpm for light, medium, and dark pigmentation, respectively.ConclusionsSpO2 and PR measurements may be inaccurate across all skin pigmentation groups, breaching U.S. Food and Drug Administration guidance and industry standard thresholds. Pulse oximeters significantly overestimate SpO2 for both light and dark skin pigmentation, but this overestimation may not be clinically relevant. PRs obtained from wearables exhibit no statistically or clinically significant bias based on skin pigmentation.

Dataset Information

Comparison of Heart Rate Feedback from Dry-Electrode ECG, 3-Lead ECG, and Pulse Oximetry during Newborn Resuscitation.

Publications

Comparison of Heart Rate Feedback from Dry-Electrode ECG, 3-Lead ECG, and Pulse Oximetry during Newborn Resuscitation.

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