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

NCT03408938 | Completed DMC

• 1 other identifier: N7-G1-2015/MD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure

Outcome Measures

Primary Outcomes (1)

• Transfusion improvement

  Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss

  24 hours

Secondary Outcomes (1)

• Agreement between SpHb and laboratory Hb values

  24 hours

Study Arms (1)

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

Interventions

of Masimo Radical-7¿ Pulse CO-Oximeter DEVICE

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

Also known as: Puls Oximeter

Continuous Hb monitoring with Masimo Radical

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• All adult high risk patients (ASA 1-2)
• Age group (16-44 years old)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Ashraf Mohamed Abd Elmawgod: collaborator
• Abdelhamid, Bassant Mohamed, M.D.: collaborator
• Hossam Eldin Mostafa Yahia: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Study Officials

• Ashraf Abdelmawgood, M.D

  Professor of Anesthesia&I.C.U and Pain Clinic

  STUDY CHAIR

• Hossam El Din Mostafa, M.S

  Assistant Lecturer of Anesthesia&I.C.U and Pain Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 24, 2018
• Study Start: April 11, 2016
• Primary Completion: December 23, 2017
• Study Completion: December 28, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)