Monitoring Noninvasively for Infusion and Transfusion Optimization

Sponsor

Masimo Corporation (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04388722

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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	N/A

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 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).

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masimo Corporation

ClinicalTrials.gov Identifier:

NCT04388722

Other Study ID Numbers:

MONITOR

First Posted:

May 14, 2020

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Postoperative Hemorrhage

Study Results

No Results Posted as of Jul 23, 2021