New Study Assesses the Utility of Masimo PVi® Monitoring During Colorectal Surgery
In the study, Dr. Warnakulasuriya and colleagues at
The researchers concluded that “amongst fit patients undergoing major colorectal surgery there was no significant difference in the volume of fluid administered when targeted by noninvasive PVi technology compared to a stroke volume maximization technique using esophageal Doppler. There was no significant difference in postoperative outcomes between the groups. Therefore, PVi offers a noninvasive, consumable free alternative for intraoperative fluid optimization in fit patients undergoing major colorectal surgery, where intraoperative goal-directed therapy is deemed a standard of care but there is no requirement for arterial cannulation.”
PVi is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In other clinical studies, PVi has been shown to provide benefits in the monitoring of mechanically-ventilated patients under general anesthesia during surgery,2,3,4,5 in the ICU in both adults and children,6,7 and in septic patients in the early stages of shock in the emergency department.8 Another study used PVi as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.9 In a study in which PVi was used in conjunction with Masimo SpHb® (noninvasive hemoglobin measurement), the technologies were shown to reduce mortality at 30 and 90 days.10
“Clinical evidence for the utility of Masimo PVi continues to amass,”
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1. Warnakulasuriya S et al. Comparison of esophageal Doppler and
plethysmographic variability index to guide intraoperative fluid therapy
for low-risk patients undergoing colorectal surgery.
2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory
Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and
Predict Fluid Responsiveness in the
3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T et al. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011;39(2):294-299.
7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91.
8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid
Responsiveness in Ventilated Patients in the Early Phase of Septic Shock
9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery
Protocol on Length of Stay, Complications, and Direct Costs after
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting,
*Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The
5. McGrath SP et al. Surveillance Monitoring Management for General Care
Units: Strategy, Design, and Implementation.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring
reduces red blood cell transfusion during neurosurgery: a prospective
cohort study. J
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting,
This press release includes forward-looking statements as defined in
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, among others, statements regarding the potential
effectiveness of Masimo PVi®. These forward-looking
statements are based on current expectations about future events
affecting us and are subject to risks and uncertainties, all of which
are difficult to predict and many of which are beyond our control and
could cause our actual results to differ materially and adversely from
those expressed in our forward-looking statements as a result of various
risk factors, including, but not limited to: risks related to our
assumptions regarding the repeatability of clinical results; risks
related to our belief that
Evan Lamb, 949-396-3376