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CompletedNCT03408938Updated Mar 29, 2018

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

An observational study in Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 16 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
16 Years to 44 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
03

Who can participate

Ages eligible
16 Years to 44 Years
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • Deviceof 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

    Also known as: Puls Oximeter

05

What researchers measure

Primary outcomes

  1. Transfusion improvement

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

    Time frame: 24 hours

Secondary outcomes

  1. Agreement between SpHb and laboratory Hb values

    The frequency of laboratory Hb testing and agreement between SpHb and laboratory Hb values

    Time frame: 24 hours

06

Study locations

1 site
  • Ahmed Abdalla Mohamed
    Cairo, 11451, Egypt
07

References and documents

Individual participant data

Plan to share: No — Via scholar Gate

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03408938
Lead sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Ashraf Mohamed Abd Elmawgod, Abdelhamid, Bassant Mohamed, M.D., Hossam Eldin Mostafa Yahia
Responsible party
Ahmed Abdalla (Assistant Professor of Anesthesia&I.C.U and Pain Clinic, Cairo University) — Principal investigator
First posted
Jan 24, 2018
Start date
Apr 11, 2016
Primary completion
Dec 23, 2017
Completion
Dec 28, 2017
Last update
Mar 29, 2018

Study contacts

Ashraf Abdelmawgood, M.D
study chair · Professor of Anesthesia&I.C.U and Pain Clinic
Hossam El Din Mostafa, M.S
study director · Assistant Lecturer of Anesthesia&I.C.U and Pain Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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