The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical -7 Pulse CO-Oximeter in Intraoperative Blood Transfusion Practice During Obstetric Procedures

The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure

The principle aim of this study is to detect the accurracy of Masimo Radical-7¿ Pulse CO-Oximeter in relation to laboratory hemoglobin and estimated blood loss in intraoperative blood transfusion practice during obstetric procedures with high risk of bleeding.

Study Overview

• Status: Completed
• Conditions: Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
• Intervention / Treatment: Device: of Masimo Radical-7¿ Pulse CO-Oximeter

Detailed Description

Photoplethysmography of peripheral perfusion can be displayed by pulse oximeters. While the pulse oximeterplethysmogram represents a volume change and the arterial line blood pressure tracing represents a pressure change, it has been demonstrated that cyclical shifts in the plethysmogram reflect similar cyclic changes in the blood pressure tracing and that these changes reflect changes in the intravascular volume status of patients.Plethysmography Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle . PVI = ﴾PI Max - PI Min﴿ ÷ PI Maxx 100 %.

PVI has the potential to provide useful information concerning changes in the balance between intrathoracic airway pressure and intravascular fluid volume. Trending of PVI may be useful in monitoring surgical patients, both intraoperatively and postoperatively, for appropriate hydration states. For example, a rising PVI may indicate developing hypovolemia and gives an alarm for the need of appropriate fluid and or blood products transfusion supported by the patient hemoglobin level.

Continuous Hb monitoring may allow a more rapid detection of clinically significant blood loss, and has the potential to significantly improve perioperative transfusion practices, may enable a more rapid assessment of a patient's condition and more appropriate blood management and even perhaps reduce needless transfusions.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 44 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Basic subject demographics summary of age, weight, height, patient position, basal lab Hb, and start time of ADC. Basic summary of number of patients, estimated blood loss, transfusions, fluids given, mean arterial blood pressure, central venous pressure, fomites number and urine output.

Description

Inclusion Criteria:

1. All adult high risk patients (ASA 1-2)
2. Age group (16-44 years old)
3. Obtetric surgery with high risk of bleeding in early and late pregnancy e.g Disturbed ectopic pregnancy ,Vesicular mole , Abortion , Placenta accrete , Rupture uterus and placenta previa

Exclusion Criteria:

1. Significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase >2.5 times normal).
2. Significant renal disease defined as (serum creatinine >1.5 mg/dl or creatinine clearance <40 ml/min).
3. Significant coagulopathy defined as (INR >1.5).
4. Use of antiplatlets or anticoagulants.
5. Anemic patients with Hb% less than 8 gm/dl

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Continuous Hb monitoring with Masimo Radical; Plethysmography Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle . PVI = ﴾PI Max - PI Min﴿ ÷ PI Maxx 100 %. PVI has the potential to provide useful information concerning changes in the balance between intrathoracic airway pressure and intravascular fluid volume. Trending of PVI may be useful in monitoring surgical patients, both intraoperatively and postoperatively, for appropriate hydration states. For example, a rising PVI may indicate developing hypovolemia and gives an alarm for the need of appropriate fluid and or blood products transfusion supported by the patient hemoglobin level

Device: of Masimo Radical-7¿ Pulse CO-Oximeter; The Masimo pulse oximetry model: The pulse oximetry model which Masimo developed accounts for saturation values contributed by the true arterial signal, and by one or more motion or noise signals. lt is assumed that under conditions of motion, the detected IR and RD signals comprise both the true arterial saturation signal and a venous (or non-arterial) motion noise signal. Masimo uses a highly sophisticated adaptive filter with, Discrete saturation transform (DST) four other parallel engines, to leverage each algorithm's unique strengths to ensure accurate readings through all patient conditions. Masimo SET's most powerful algorithm is Signal extraction technology (SET). All algorithms depend upon assumptions. The more assumptions, the weaker the algorithm. DST makes only one assumption -that arterial blood has a higher oxygenation than venous - making it the most powerful pulse oximetry algorithm; Other Names: Puls Oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion improvement	Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between SpHb and laboratory Hb values	The frequency of laboratory Hb testing and agreement between SpHb and laboratory Hb values	24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Abdelhamid, Bassant Mohamed, M.D.; Mohamed, Ahmed A., M.D.; Ashraf Mohamed Abd Elmawgod; Hossam Eldin Mostafa Yahia
• Investigators: Study Chair: Ashraf Abdelmawgood, M.D, Professor of Anesthesia&I.C.U and Pain Clinic; Study Director: Hossam El Din Mostafa, M.S, Assistant Lecturer of Anesthesia&I.C.U and Pain Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2016
• Primary Completion (ACTUAL): December 23, 2017
• Study Completion (ACTUAL): December 28, 2017

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: N7-G1-2015/MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Via scholar Gate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No