Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric ProcedureNCT03408938
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 of Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
- What is being tested?
- of Masimo Radical-7¿ Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2016to 28 Dec 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
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.
- Being tested
- of Masimo Radical-7¿ Pulse CO-Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
of Masimo Radical-7¿ Pulse CO-OximeterDevice
Also called Puls 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: of Masimo Radical-7¿ Pulse CO-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion improvement
Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start11 Apr 2016
- Primary completion23 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric ProcedureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Ashraf Mohamed Abd Elmawgod, Abdelhamid, Bassant Mohamed, M.D., Hossam Eldin Mostafa Yahia
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ashraf Abdelmawgood, M.D, Study chair, Professor of Anesthesia&I.C.U and Pain ClinicHossam El Din Mostafa, M.S, Study director, Assistant Lecturer of Anesthesia&I.C.U and Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408938
- Sponsor's protocol ID
- N7-G1-2015/MD
- Status last verified
- Mar 2018
- First submitted
- 29 Dec 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Via scholar Gate
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure
- ClinicalTrials.gov ID
- NCT03408938
- Acronym / sponsor ID
- N7-G1-2015/MD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Ashraf Mohamed Abd Elmawgod, Abdelhamid, Bassant Mohamed, M.D., Hossam Eldin Mostafa Yahia
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Hb monitoring with Masimo Radical | – | Device: of Masimo Radical-7¿ Pulse CO-OximeterPlethysmography 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 |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| of Masimo Radical-7¿ Pulse CO-OximeterAlso: Puls OximeterThe 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 | Device | Continuous Hb monitoring with Masimo Radical |
Primary outcome
Transfusion improvement
Time frame: 24 hours
Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss
1 secondary outcome
Agreement between SpHb and laboratory Hb values
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No. Via scholar Gate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion improvement (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.