Monitoring Noninvasively for Infusion and Transfusion Optimization

Monitoring Noninvasively for Infusion and Transfusion Optimization in a Randomized (MONITOR) Trial

This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.

Study Overview

• Status: Withdrawn
• Conditions: Hypovolemia; Post Operative Hemorrhage; Transfusion Related Complication; Blood Transfusion Associated Adverse Reactions
• Intervention / Treatment: Device: Pulse CO-Oximeter Sensor

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Arm	Device: Pulse CO-Oximeter Sensor; Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb) and pleth variability index (PVi).
No Intervention: Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complication	Occurrence of at least one post-operative complication by day 7 after surgery.	7 days

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Postoperative Complications; Hematologic Diseases; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Transfusion Reaction; Hypovolemia
• Other Study ID Numbers: MONITOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes