Monitoring Noninvasively for Infusion and Transfusion Optimization

• ClinicalTrials.gov Identifier: NCT04388722
• Recruitment Status: Withdrawn
• First Posted: May 14, 2020
• Last Update Posted: December 14, 2020
• Sponsor: Masimo Corporation
• Information provided by (Responsible Party): Masimo Corporation

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.

Condition or disease	Intervention/treatment	Phase
Post Operative Hemorrhage; Transfusion Related Complication; Blood Transfusion Associated Adverse Reactions; Hypovolemia	Device: Pulse CO-Oximeter Sensor	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Monitoring Noninvasively for Infusion and Transfusion Optimization in a Randomized (MONITOR) Trial
• Estimated Study Start Date: December 10, 2020
• Estimated Primary Completion Date: December 10, 2020
• Estimated Study Completion Date: December 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Post-operative complication [ Time Frame: 7 days ]
   Occurrence of at least one post-operative complication by day 7 after surgery.

Eligibility Criteria

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT04388722
• Other Study ID Numbers: MONITOR
• First Posted: May 14, 2020
• Last Update Posted: December 14, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Transfusion Reaction; Hemorrhage; Hypovolemia; Blood Loss, Surgical; Postoperative Hemorrhage; Pathologic Processes; Intraoperative Complications; Postoperative Complications; Hematologic Diseases; Immune System Diseases