Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers

doi:10.1016/j.jclinane.2011.10.012

Journal of Clinical Anesthesia

Volume 24, Issue 5, August 2012, Pages 385-391

https://doi.org/10.1016/j.jclinane.2011.10.012 Get rights and content

Abstract

Study Objective

To evaluate pulse oximeter performance during motion and induced low perfusion in volunteers.

Design

Prospective volunteer study.

Setting

Direct Observation unit.

Subjects

10 healthy adult volunteers.

Interventions

Ten volunteers were monitored with three different pulse oximeters while they underwent desaturation to about 75% oxygen saturation (SpO₂) and performed machine-generated (MG) and volunteer-generated (VG) hand movements with the test hand, keeping the control hand stationary.

Measurements

SpO₂ and pulse rate readings from the motion (test) and stationary (control) hands were recorded as well as the number of times and the duration that the oximeters connected to the test hands did not report a reading. Sensitivity, specificity, performance index for SpO₂, and pulse rate (PR) were calculated for each pulse oximeter by comparing performance of the test hand with the control hand.

Main Results

During both MG and VG motion, the Masimo Radical had higher SpO₂ specificity (93% and 97%) than the Nellcor N-600 (67% and 77%) or the Datex-Ohmeda TruSat (83% and 82%). The Masimo Radical also had higher SpO₂ sensitivity (100% and 95%) than the Nellcor N-600 (65% and 50%) or the Datex-Ohmeda TruSat (20% and 15%) during both MG and VG motion. During MG motion, the Masimo Radical had the lowest PR failure rate (0%) compared with the Nellcor N-600 (22.2%) and Datex-Ohmeda TruSat (1.3%). However, during VG motion, the Masimo Radical had the lowest SpO₂ failure rate (0%) of the three devices (Nellcor N-600 16.4% and Datex-Ohmeda TruSat 1.7%). Both the Masimo Radical and the Datex-Ohmeda TruSat had lower PR failure rates (0% and 4.4%) than the Nellcor N-600 (33.9%). There were no significant differences in SpO₂ or PR performance index between the three devices.

Conclusions

The Masimo Radical had higher SpO₂ sensitivity and specificity than the Nellcor N-600 and Datex-Ohmeda TruSat during conditions of motion and induced low perfusion in this volunteer study.

Introduction

Oxygen saturation (SpO₂) is the estimate of the oxygen saturation of hemoglobin. Continuous monitoring of SpO₂ enables clinicians to detect hypoxemia at an early stage and intervene to prevent any dire consequences. Pulse oximeters provide immediate, continuous, and noninvasive monitoring of SpO₂ without the need for calibration and frequent sensor replacement [1].

Conventional pulse oximeters have significant limitations, including high rates of false alarms and failed measurements when used on patients with low perfusion or during patient motion [2], [3], [4], [5], [6]. This high false-alarm rate incurs the risk of desensitizing clinical care givers to true alarms [7]. Failed measurements are another significant limitation. Earlier work showed that pulse oximeters failed in the operating room in 2.5% of 10,312 patients randomized to be monitored [8]. Pulse oximeter failure rates are even higher in critical care, intensive care, and Postanesthesia Care Unit (PACU) environments [9]. New-generation pulse oximeters are designed to overcome these limitations. The newer-generation pulse oximeters have fewer false alarms and higher accuracy than conventional pulse oximeters [10], [11], [12], [13].

In this study, we evaluated the performance of three new-generation pulse oximeters [Masimo Radical (V 5.0), Nellcor N-600 (V 1.1.2.0), and Datex-Ohmeda TruSat] in a cool environment to mimic reduced perfusion and during induced motion. Both machine-generated (MG) motion (standardized and reproducible) and volunteer-generated (VG) motion (more challenging for pulse oximeter sensors) were used [14]. Both hypoxic and normoxic conditions were studied.

Section snippets

Materials and methods

After Institutional Review Board of the Long Beach VAHS, CA approval and informed consent, 10 healthy, ASA physical status 1 volunteers (5 women), ranging in age from 22 to 30 years (mean age 26 yrs), were studied. Earlier studies of pulse oximeter performance studied 10 healthy volunteers and had obtained statistically significant results [13], [14]. All subjects were nonsmokers with no evidence of vascular or other systemic disease. Each subject was monitored with three oximeter sensors: the

Results

A total of 160 motion tests were performed (80 with machine-generated motion, 80 with volunteer-generated motion, 40 with desaturation, and 120 on room air) on 10 study volunteers. Missed events were counted out of 40 tests during hypoxemia (20 with machine motion and 20 with volunteer motion), and false alarms were counted out of 120 tests during normoxia (60 with machine motion and 60 with volunteer motion).

The range in average temperatures for each experimental condition for all subjects was

Discussion

Our study involved volunteer subjects in a laboratory setting. Such studies allow investigators to use a more rigorous protocol while maintaining control over variables. The major disadvantage of laboratory studies is that they may not fully replicate the characteristics of complex clinical settings such as the different types of motions exhibited by patient populations [17]. The potential of unrecognized hypoxemia, however, mandates that research in volunteers mimic actual clinical scenarios

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^☆: Financial Support: Supported in part by Masimo Corporation, Irvine, CA, USA, which provided equipment and a grant for the study.

^☆☆: Conflict of interest: Dr. Shah is a Speaker Board Member, Advisory Board Member, & Stock holder in Masimo Corporation, Irvine, CA, USA.

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Published by Elsevier Inc.

Original ContributionPerformance of three new-generation pulse oximeters during motion and low perfusion in volunteers☆,☆☆

Abstract

Study Objective

Design

Setting

Subjects

Interventions

Measurements

Main Results

Conclusions

Introduction

Section snippets

Materials and methods

Results

Discussion

J Clin Anesth

Noninvasive monitoring of oxygenation in infants and children: practical considerations and areas of concern

Pediatrics

Blood flow limits and pulse oximeter signal detection

Anesthesiology

Pulse oximeter failure thresholds in hypotension and vasoconstriction

Anesthesiology

Conscious sedation and pulse oximetry: false alarms?

Pediatr Dent

Evaluation of the influence of movement on saturation readings from pulse oximeters

Anaesthesia

Crying wolf: false alarms in a pediatric intensive care unit

Crit Care Med

Randomized evaluation of pulse oximetry in 20,802 patients: II. Perioperative events and postoperative complications

Anesthesiology

Hypoxaemia during postoperative recovery using continuous pulse oximetry

Anaesth Intensive Care

Original Contribution
Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers☆,☆☆