Clinical trial NCT03408938: The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical -7 Pulse CO-Oximeter in Intraoperative Blood Transfusion Practice During Obstetric Procedures
Official title: The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Mohamed, Ahmed A., M.D.
name: Ashraf Mohamed Abd Elmawgod
name: Abdelhamid, Bassant Mohamed, M.D.
name: Hossam Eldin Mostafa Yahia
First posted: 2018-01-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transfusion improvement
timeFrame: 24 hours
Secondary outcomes:
measure: Agreement between SpHb and laboratory Hb values
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
affiliation: Professor of Anesthesia&I.C.U and Pain Clinic
name: Ashraf Abdelmawgood, M.D
role: STUDY_CHAIR
affiliation: Assistant Lecturer of Anesthesia&I.C.U and Pain Clinic
name: Hossam El Din Mostafa, M.S
role: STUDY_DIRECTOR
References: