Sponsor study identifier
observational
60
1 country
1
Study Start
April 11, 2016
Actual (reported)Primary Completion
December 23, 2017
Actual (reported)Study Completion
December 28, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2016
Actual (reported)December 23, 2017
Actual (reported)December 28, 2017
Actual (reported)December 29, 2017
Actual (reported)January 24, 2018
Actual (reported)Transfusion improvement
Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss
24 hours
Agreement between SpHb and laboratory Hb values
24 hours
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
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
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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.
Ahmed Abdalla Mohamed
Cairo, 11451, Egypt
Ashraf Abdelmawgood, M.D
Professor of Anesthesia&I.C.U and Pain Clinic
Hossam El Din Mostafa, M.S
Assistant Lecturer of Anesthesia&I.C.U and Pain Clinic
60 participants (actual enrollment reported by the registry).
First Submitted
December 29, 2017
First Posted
January 24, 2018
Study Start
April 11, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 23, 2017
Actual (reported)Study Completion
December 28, 2017
Actual (reported)Last Updated
March 29, 2018
Record last verified: 2018-03
Via scholar Gate
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Source: ClinicalTrials.gov.
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