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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Withdrawn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

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

NCT ID

NCT04388722

First Posted

May 12, 2020

Last Updated

July 22, 2021

Sponsor

Masimo Corporation

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

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

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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