Monitoring Noninvasively for Infusion and Transfusion Optimization

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04388722
• Other study ID #: MONITOR
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Blood Transfusion Associated Adverse Reactions
• Hemorrhage
• Hypovolemia
• Post Operative Hemorrhage
• Postoperative Hemorrhage
• Transfusion Reaction
• Transfusion Related Complication

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative complication	Occurrence of at least one post-operative complication by day 7 after surgery.	7 days