Monitoring Noninvasively for Infusion and Transfusion Optimization
Primary Purpose
Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulse CO-Oximeter Sensor
Sponsored by
About this trial
This is an interventional other trial for Post Operative Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 18 years or older at the time of consent.
- Ability to provide written informed consent.
- Scheduled for non-urgent major surgery with general anesthesia
- At least one finger available and accessible for performing non-invasive pleth variability index (PVi) and hemoglobin (SpHb) monitoring.
- The Attending surgeon, attending anesthesiologist and the clinical care team agree with enrollment in the study, including the restrictions on monitoring procedures defined in the control group.
Exclusion Criteria:
- Untreated or uncontrolled hypertension defined as mean arterial pressure (MAP) greater than 120 mmHg, despite medications.
- Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease.
- Surgeries where no bleeding is expected to occur (i.e., total knee surgery where blood loss is prevented by use of tourniquet).
- Surgeries performed in the prone position.
- Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome.
- Aortic pathology that could lead to misinterpretation of hemodynamic variables (e.g. intra- aortic balloon pump, thoracic aorta aneurysm).
- Renal vascular surgery.
- Preoperative sepsis.
- Circulatory shock.
- Preoperative vasoactive substance infusion before study entry.
- Concurrent participation in any interventional study.
- Pregnant or lactating women.
- Patients who refuse to receive blood transfusion(s).
- Patients with Do Not Resuscitate (DNR) orders.
- Open chest surgeries.
- Prisoners
- Patients for whom monitoring of CO, SV, PPV, and/or SVV to guide GDT or similar intra-operative fluid management, including continuous SpHb monitoring, would be standard of care.
- Patients have skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors.
- Cardio-pulmonary bypass (CPB) surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
Investigational Arm
Arm Description
Outcomes
Primary Outcome Measures
Post-operative complication
Occurrence of at least one post-operative complication by day 7 after surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04388722
Brief Title
Monitoring Noninvasively for Infusion and Transfusion Optimization
Official Title
Monitoring Noninvasively for Infusion and Transfusion Optimization in a Randomized (MONITOR) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor's decision to withdraw study.
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions, Hypovolemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Title
Investigational Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Pulse CO-Oximeter Sensor
Intervention Description
Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb) and pleth variability index (PVi).
Primary Outcome Measure Information:
Title
Post-operative complication
Description
Occurrence of at least one post-operative complication by day 7 after surgery.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older at the time of consent.
Ability to provide written informed consent.
Scheduled for non-urgent major surgery with general anesthesia
At least one finger available and accessible for performing non-invasive pleth variability index (PVi) and hemoglobin (SpHb) monitoring.
The Attending surgeon, attending anesthesiologist and the clinical care team agree with enrollment in the study, including the restrictions on monitoring procedures defined in the control group.
Exclusion Criteria:
Untreated or uncontrolled hypertension defined as mean arterial pressure (MAP) greater than 120 mmHg, despite medications.
Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease.
Surgeries where no bleeding is expected to occur (i.e., total knee surgery where blood loss is prevented by use of tourniquet).
Surgeries performed in the prone position.
Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome.
Aortic pathology that could lead to misinterpretation of hemodynamic variables (e.g. intra- aortic balloon pump, thoracic aorta aneurysm).
Renal vascular surgery.
Preoperative sepsis.
Circulatory shock.
Preoperative vasoactive substance infusion before study entry.
Concurrent participation in any interventional study.
Pregnant or lactating women.
Patients who refuse to receive blood transfusion(s).
Patients with Do Not Resuscitate (DNR) orders.
Open chest surgeries.
Prisoners
Patients for whom monitoring of CO, SV, PPV, and/or SVV to guide GDT or similar intra-operative fluid management, including continuous SpHb monitoring, would be standard of care.
Patients have skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent the proper fit and application of the sensors.
Cardio-pulmonary bypass (CPB) surgery.
12. IPD Sharing Statement
Learn more about this trial
Monitoring Noninvasively for Infusion and Transfusion Optimization
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