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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Withdrawn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
Masimo Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 12, 2020
    Last Updated
    July 22, 2021
    Sponsor
    Masimo Corporation
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    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

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