Clinical Evidence

 

Clinical Studies

Masimo is passionate about making innovative technologies that give clinicians the tools they need to do what is best for patient care. That's why it is gratifying to see so many clinicians and clinical researchers take the time to evaluate our products and technologies.

Click on the links below to read featured studies for Masimo’s technologies, or in the sections below for access by subject area to all studies.

Featured Clinical Studies

 

Masimo SET® Pulse Oximetry

Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients.

Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy C. Pediatr Crit Care Med. 2016 Apr;17(4):315-20.

Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers.

Shah N., Ragaswamy H.B., Govindugari K., Estanol L. J Clin Anesth. 2012 Aug;24(5):385-91.

Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology.

Castillo A., Deulofeut R., Critz A., Sola A. Acta Paediatr. 2011 Feb;100(2):188-92.

Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns.

de-Wahl Granelli A., Wennergren M., Sandberg K., Mellander M., Bejlum C., Inganäs L., Eriksson M., Segerdahl N., Agren A., Ekman-Joelsson B.M., Sunnegårdh J., Verdicchio M., Östman-Smith I. BMJ. 2009;Jan 8;338.

More Reliable Oximetry Reduces the Frequency of Arterial Blood Gas Analyses and Hastens Oxygen Weaning after Cardiac Surgery: A Prospective, Randomized Trial of the Clinical Impact of a New Technology.

Durbin C.G. Jr., Rostow S.K. Crit Care Med. 2002 Aug;30(8):1735-40.

Reliability of Conventional and New Pulse Oximetry in Neonatal Patients.

Hay W.W., Rodden D.J., Collins S.M., Melara D.L., Hale K.A., Fashaw L.M. J Perinatol. 2002 Jul-Aug;22(5):360-6.

"Motion-Resistant" Pulse Oximetry: A Comparison of New and Old Models.

Barker S.J. Anesth Analg. 2002 Oct;95(4):967-72.

Pleth Variability Index (PVi®)

Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery

Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Journal of the American College of Surgeons (2015), doi: 10.1016/j.jamcollsurg.2014.12.042.

Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management

Forget P, Lois F, de Kock M. Anesth Analg. 2010 Oct;111(4):910-4.

Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre

Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot J.J. Br J Anaesth. 2008 Aug;101(2):200-6.

Masimo Patient SafetyNet™**

Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study.

Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.

Postoperative Monitoring – The Dartmouth Experience.

Taenzer A.H., Blike, G. T. APSF Newsletter 2012. Available at:http://www.apsf.org/newsletters/html/2012/spring/01_postop.htm Accessed June 14, 2012.

Total Hemoglobin (SpHb®)

Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study.

Awada WN, Mohmoued MF, Radwan TM, Hussien GZ, Elkady HW. J Clin Monit Comput. 2015 Feb 4. [Epub ahead of print] PubMed PMID: 25649717.

Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial

Ehrenfeld JM, Henneman JP, Bulka CM, Sandberg WS. 2014. J Blood Disorders Transf 5:237.doi:10.4172/2155-9864.1000237.

Trending and Accuracy of Noninvasive Hemoglobin Monitoring in Pediatric Perioperative Patients

Patino M, Schultz L, Hossain M, Moeller J, Mahmoud M, Gunter J, Kurth CD. Anesth Analg. 2014 Jul 17. [Epub ahead of print] PubMed PMID: 25036374.

Accuracy of a Continuous Noninvasive Hemoglobin Monitor in Intensive Care Unit Patients.

Frasca D., Dahyot-Fizelier C., Catherine K., Levrat Q., Debaene B., Mimoz O. Crit Care Med. 2011 Oct;39(10):2277-82.

The Accuracy of Noninvasive and Continuous Total Hemoglobin Measurement by Pulse CO-Oximetry in Human Subjects Undergoing Hemodilution.

Macknet M.R., Allard M., Applegate R.L., Rook J. Anesth Analg. 2010 Dec;111(6):1424–6.

Reduction in Red Blood Cell Transfusions during Neurosurgery with Noninvasive and Continuous Hemoglobin Monitoring

Awada WNFM et al. Anesth Analg 2013; (117 suppl): 50 (abstract).

Acoustic Respiration Rate (RRa®)

 

Accuracy of respiratory rate monitoring using a non-invasive acoustic method after general anaesthesia.

Mimoz O., Benard T., Gaucher A., Frasca D., Debaene B. Br J Anaesth. 2012 May;108(5):872-5.

Accuracy of Respiration Rate and Detection of Respiratory Pause by Acoustic Respiratory Monitoring in the PACU.

Ramsay M.A., Lagow E., Usman M. 65th Annual Post Graduate Assembly in Anesthesiology. December 9-11, 2011. Abs P-9137.

Monitoring Respiration in Upper GI Endoscopy Anesthesia.

Goudra B.G., Penugonda L. Proceedings of the 2011 Annual Meeting of the American Society of Anesthesiologists. A246.

Accuracy and Tolerance of a Novel Bioacoustic Respiratory Sensor in Pediatric Patients

Macknet M.R., Kimball-Jones P.L., Applegate R.L., Martin R.D., Allard M.W. Anesthesiology. 2007; 107: A84.

Carboxyhemoglobin (SpCO®)

Accuracy of Noninvasive Multiwave Pulse Oximetry Compared With Carboxyhemoglobin From Blood Gas Analysis in Unselected Emergency Department Patients.

Roth D., Herkner H., Schreiber W., Hubmann N., Gamper G., Laggner A.N., Havel C. Ann Emerg Med. 2011 Jul;58(1):74-9.

Noninvasive Pulse CO-Oximetry Expedites Evaluation and Management of Patients with Carbon Monoxide Poisoning.

Hampson N.B. Am J Emerg Med. 2012 Nov;30(9):2021-4.

Methemoglobin (SpMet®)

Severe Methemoglobinemia Detected by Pulse Oximetry.

Annabi E.H., Barker S,J. Anesth Analg. 2009;108:898–9.

Oxygen Reserve Index (ORi™)

Study of early warning for desaturation provided by Oxygen Reserve Index in obese patients

Tsymbal E, Ayala S, Singh A, Applegate RL 2nd, Fleming NW. [published online ahead of print, 2020 May 18]. J Clin Monit Comput. 2020;10. doi:10.1007/s10877-020-00531-w

Oxygen Reserve Index Predicts Hypoxemia During One-Lung Ventilation: An Observational Diagnostic Study.

Alday E, Nieves JM, Planas A. J Cardiothorac VascAnesth. 2020 Feb;34(2):417-422.

The oxygen reserve index (ORi): a new tool to monitor oxygen therapy

Scheeren TWL, FJ Belda, A Perel. J Clin Monit Comput, 2017. DOI 10.1007/s10877-017-0049-4.

The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery.

Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. Anesth Analg. 2016 Mar 22. [Epub ahead of print] PubMed PMID: 27007078.

Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study.

Szmuk P, Steiner JW, Olomu, PN, Ploski, RP, Sessler, DI, Ezri, T. Anesthesiology 2016; 124:00-00. doi:10.1097/ALN.0000000000001009

Oxygen Reserve Index - a New, Noninvasive Method of Oxygen Reserve Measurement

Szmuk P, Steiner J., Olomu P., Dela Cruz J., Sessler D. American Society of Anesthesiologists 2014; BOC12.

Regional Oximetry (O3®)

Absolute and Trend Accuracy of a New Regional Oximeter in Healthy Volunteers During Controlled Hypoxia.

Redford D, Paidy S, Kashif F. Anesth Analg. 2014 Dec; 119(6):1315-1319. PubMed PMID: 25405692.

SedLine® Brain Function Monitoring

 

Titration of Delivery and Recovery from Propofol, Alfentanil, and Nitrous Oxide Anesthesia.

Drover D.R., Lemmens H.J., Pierce E.T., Plourde G., Loyd G., Ornstein E., Prichep L.S., Chabot R.J., Gugino L. Anesthesiology 2002; 97:82–9.

Masimo Capnography and Gas Monitoring

Evaluation of a Transportable Capnometer for Monitoring End-Tidal Carbon Dioxide.

Hildebrandt T., Espelund M., Olsen K.S. Anaesthesia. 2010 Oct;65(10):1017-21.

TNI softFlow50®

Nasal high-flow versus noninvasive ventilation in patients with chronic hypercapnic COPD.

Bräunlich et al. Int J Chron Obstruct Pulmon Dis 2019;(14):1411-1421.

Reductions in dead space ventilation with nasal high flow depend on physiological dead space volume: metabolic hood measurements during sleep in patients with COPD and controls.

Biselli et al. Eur Respir J 2018;51:1702251.

Nasal high-flow therapy reduces work of breathing compared with oxygen during sleep in COPD and smoking controls: a prospective observational study.

Biselli et al. J Appl Physiol (1985). 2017;122(1):82-88.

Nasal highflow improves ventilation in patients with COPD.

Bräunlich J et al.
Int J Chron Obstruct Pulmon Dis. 2016;(11):1077-1085.

The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

Masimo devices with SpHb, SpCO, and/or SpMet monitoring are not intended to replace laboratory blood testing. Blood samples should be analysed by laboratory instruments prior to clinical decision making.

Duplicate abstracts or publications are excluded

This section is intended to provide access to clinical studies conducted using Masimo noninvasive technologies, parameters, and products. We cannot guarantee that all published clinical studies, abstracts and research are listed here. To view individual clinical studies please click on the appropriate tab.

Some uses of the manufacturer’s devices described in the information may not have been approved or cleared by the FDA. See manufacturer labeling for the indications in the product’s cleared indications for use statement.

Clinical evidence is provided to illustrate the performance and accuracy of Masimo technologies. Federal law restricts Masimo devices for medical uses to sale by or on the order of a physician.

PLCO-004090/PLM-10313G-0920