Bergese Sergio D, Mestek Michael L, Kelley Scott D, McIntyre Robert, Uribe Alberto A, Sethi Rakesh, Watson James N, Addison Paul S
From the Departments of *Anesthesiology and †Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio; ‡Respiratory & Monitoring Solutions, Medtronic, Boulder, Colorado; §Department of Surgery, University of Colorado Hospital, Aurora, Colorado; and ‖Respiratory & Monitoring Solutions, Medtronic, Edinburgh, United Kingdom.
Anesth Analg. 2017 Apr;124(4):1153-1159. doi: 10.1213/ANE.0000000000001852.
Intermittent measurement of respiratory rate via observation is routine in many patient care settings. This approach has several inherent limitations that diminish the clinical utility of these measurements because it is intermittent, susceptible to human error, and requires clinical resources. As an alternative, a software application that derives continuous respiratory rate measurement from a standard pulse oximeter has been developed. We sought to determine the performance characteristics of this new technology by comparison with clinician-reviewed capnography waveforms in both healthy subjects and hospitalized patients in a low-acuity care setting.
Two independent observational studies were conducted to validate the performance of the Medtronic Nellcor Respiration Rate Software application. One study enrolled 26 healthy volunteer subjects in a clinical laboratory, and a second multicenter study enrolled 53 hospitalized patients. During a 30-minute study period taking place while participants were breathing spontaneously, pulse oximeter and nasal/oral capnography waveforms were collected. Pulse oximeter waveforms were processed to determine respiratory rate via the Medtronic Nellcor Respiration Rate Software. Capnography waveforms reviewed by a clinician were used to determine the reference respiratory rate.
A total of 23,243 paired observations between the pulse oximeter-derived respiratory rate and the capnography reference method were collected and examined. The mean reference-based respiratory rate was 15.3 ± 4.3 breaths per minute with a range of 4 to 34 breaths per minute. The Pearson correlation coefficient between the Medtronic Nellcor Respiration Rate Software values and the capnography reference respiratory rate is reported as a linear correlation, R, as 0.92 ± 0.02 (P < .001), whereas Lin's concordance correlation coefficient indicates an overall agreement of 0.85 ± 0.04 (95% confidence interval [CI] +0.76; +0.93) (healthy volunteers: 0.94 ± 0.02 [95% CI +0.91; +0.97]; hospitalized patients: 0.80 ± 0.06 [95% CI +0.68; +0.92]). The mean bias of the Medtronic Nellcor Respiration Rate Software was 0.18 breaths per minute with a precision (SD) of 1.65 breaths per minute (healthy volunteers: 0.37 ± 0.78 [95% limits of agreement: -1.16; +1.90] breaths per minute; hospitalized patients: 0.07 ± 1.99 [95% limits of agreement: -3.84; +3.97] breaths per minute). The root mean square deviation was 1.35 breaths per minute (healthy volunteers: 0.81; hospitalized patients: 1.60).
These data demonstrate the performance of the Medtronic Nellcor Respiration Rate Software in healthy subjects and patients hospitalized in a low-acuity care setting when compared with clinician-reviewed capnography. The observed performance of this technology suggests that it may be a useful adjunct to continuous pulse oximetry monitoring by providing continuous respiratory rate measurements. The potential patient safety benefit of using combined continuous pulse oximetry and respiratory rate monitoring warrants assessment.
在许多患者护理环境中，通过观察间歇性测量呼吸频率是常规操作。这种方法有几个固有的局限性，会降低这些测量的临床效用，因为它是间歇性的，易受人为误差影响，且需要临床资源。作为一种替代方法，已开发出一种从标准脉搏血氧仪获取连续呼吸频率测量值的软件应用程序。我们试图通过在低 acuity 护理环境中的健康受试者和住院患者中，将这项新技术与临床医生审查的二氧化碳描记图波形进行比较，来确定其性能特征。
进行了两项独立的观察性研究，以验证美敦力 Nellcor 呼吸频率软件应用程序的性能。一项研究在临床实验室招募了 26 名健康志愿者受试者，另一项多中心研究招募了 53 名住院患者。在参与者自主呼吸的 30 分钟研究期间，收集脉搏血氧仪和鼻/口腔二氧化碳描记图波形。通过美敦力 Nellcor 呼吸频率软件处理脉搏血氧仪波形以确定呼吸频率。由临床医生审查的二氧化碳描记图波形用于确定参考呼吸频率。
总共收集并检查了 23243 对脉搏血氧仪得出的呼吸频率与二氧化碳描记图参考方法之间的观察值。基于参考的平均呼吸频率为每分钟 15.3±4.3 次呼吸，范围为每分钟 4 至 34 次呼吸。美敦力 Nellcor 呼吸频率软件值与二氧化碳描记图参考呼吸频率之间的 Pearson 相关系数报告为线性相关，R 为 0.92±0.02（P<.001），而 Lin 一致性相关系数表明总体一致性为 0.85±0.04（95%置信区间[CI]+0.76；+0.93）（健康志愿者：0.94±0.02[95%CI+0.91；+0.97]；住院患者：0.80±0.06[95%CI+0.68；+0.92]）。美敦力 Nellcor 呼吸频率软件的平均偏差为每分钟 0.18 次呼吸，精度（标准差）为每分钟 1.65 次呼吸（健康志愿者：0.37±0.78[95%一致性界限：-1.16；+1.90]次呼吸/分钟；住院患者：0.07±1.99[95%一致性界限：-3.84；+3.97]次呼吸/分钟）。均方根偏差为每分钟 1.35 次呼吸（健康志愿者：0.81；住院患者：1.60）。
这些数据证明了美敦力 Nellcor 呼吸频率软件在健康受试者和低 acuity 护理环境中住院患者中的性能，与临床医生审查的二氧化碳描记图相比。该技术观察到的性能表明，通过提供连续呼吸频率测量，它可能是连续脉搏血氧饱和度监测的有用辅助手段。使用联合连续脉搏血氧饱和度和呼吸频率监测对患者安全的潜在益处值得评估。
