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Trial record 4 of 620 for:    oximeter

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

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ClinicalTrials.gov Identifier: NCT03408938
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Mohamed, Ahmed A., M.D.
Ashraf Mohamed Abd Elmawgod
Abdelhamid, Bassant Mohamed, M.D.
Hossam Eldin Mostafa Yahia
Information provided by (Responsible Party):
Ahmed Abdalla, Cairo University

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.

Condition or disease Intervention/treatment
Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
Actual Study Start Date : April 11, 2016
Actual Primary Completion Date : December 23, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine


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 Name: Puls Oximeter




Primary Outcome Measures :
  1. Transfusion improvement [ Time Frame: 24 hours ]
    Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss


Secondary Outcome Measures :
  1. Agreement between SpHb and laboratory Hb values [ Time Frame: 24 hours ]
    The frequency of laboratory Hb testing and agreement between SpHb and laboratory Hb values



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Ages Eligible for Study:   16 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408938


Locations
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Egypt
Ahmed Abdalla Mohamed
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
Mohamed, Ahmed A., M.D.
Ashraf Mohamed Abd Elmawgod
Abdelhamid, Bassant Mohamed, M.D.
Hossam Eldin Mostafa Yahia
Investigators
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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

Additional Information:

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Responsible Party: Ahmed Abdalla, Assistant Professor of Anesthesia&I.C.U and Pain Clinic, Cairo University
ClinicalTrials.gov Identifier: NCT03408938     History of Changes
Other Study ID Numbers: N7-G1-2015/MD
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Via scholar Gate

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No