Study Investigates Performance of Masimo PVi® As Part of Goal-Directed Fluid Therapy During Laparoscopic Bariatric Surgery
In the study, Dr. Demirel and colleagues sought to evaluate whether using GDFT guided by PVi on morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (RYGB) surgery might result in less intravenous fluid use without compromising outcomes. They enrolled 60 patients and divided them randomly into control and GDFT groups. The control group’s fluid levels were managed by standard fluid therapy, using mean arterial pressure (MAP) and central venous pressure (CVP) measured via a central venous access catheter as indicators of fluid responsiveness. The GDFT group’s fluid status was monitored using a GDFT protocol based on PVi as a noninvasive, dynamic indicator of fluid responsiveness.
Both groups were initially administered 500 mL bolus colloid fluid at the beginning of surgery, followed by a continuous infusion of crystalloid fluid (4-8 mL/kg/h in the control group, or 2 mL/kg/h in the GDFT group per the protocol). In the control group, if CVP was less than 6 mmHg or MAP less than 65 mmHg, a 250 mL additional bolus of colloid fluid was administered. In the GDFT group, if PVi was greater than 14% for five minutes, the 250 mL colloid bolus was administered.
The researchers found that there was a significantly higher mean volume of crystalloid fluid administered in the control group (1499 mL ± 516.87 mL) compared to the GDFT group (1126 mL ± 234.98 mL) (p = 0.001). There were no significant differences in blood lactate levels (p > 0.05) or creatinine levels before and after surgery (p > 0.05) between the two groups.
The researchers concluded that, “Utilization of GDFT protocols based on PVi may prevent excessive intraoperative infusion of fluids in laparoscopic bariatric surgery. This method when intending to prevent intraoperative excessive fluid loading in RYGB surgery appears to have no effect on either renal functions or lactate levels. While this study shows the adequacy of PVi for fluid therapy in mechanically ventilated patients undergoing bariatric surgery, further research is warranted to assess adequacy of optimization of PVi.”
@MasimoInnovates | #Masimo
Demirel I, Bolat E, Altun AY, Özdemir M, and Beştaş A. Efficacy of
Goal-Directed Fluid Therapy via Pleth Variability Index During
Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese
Patients. Obes Surg.
31 July 2017. DOI: 10.1007/s11695-017-2840-1.
ORi has not received
*The use of the trademark Patient SafetyNet is under license from
- 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.
- 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.
- 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.
- Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
McGrath SP et al. Surveillance Monitoring Management for General Care
Units: Strategy, Design, and Implementation.
The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
Masimodata on file.
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