Monitoring Noninvasively for Infusion and Transfusion Optimization

NCT04388722 | Withdrawn FDA Device

• 1 other identifier: MONITOR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Operative Hemorrhage; Transfusion Related Complication; Blood Transfusion Associated Adverse Reactions; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• Post-operative complication

  Occurrence of at least one post-operative complication by day 7 after surgery.

  7 days

Study Arms (2)

Control Arm

NO INTERVENTION

Investigational Arm

EXPERIMENTAL

Device: Pulse CO-Oximeter Sensor

Interventions

Pulse CO-Oximeter Sensor DEVICE

Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb) and pleth variability index (PVi).

Investigational Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

MeSH Terms

Conditions

Postoperative Hemorrhage; Transfusion Reaction; Hypovolemia

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07