Trial Outcomes & Findings for Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes (NCT NCT02986789)

Last Updated: 2025-11-12

Results Overview

Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.

Recruitment status

TERMINATED

Target enrollment

43 participants

Primary outcome timeframe

Approximately 6-8 hours

Results posted on

2025-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Clinicians will be performing blood transfusions using hospital standard of care procedures.	Evaluation Group Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures. In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)
Overall Study STARTED	43	0
Overall Study COMPLETED	43	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=43 Participants Clinicians will be performing blood transfusions using hospital standard of care procedures.	Evaluation Group Clinicians will be guiding blood transfusions using SpHb with In vivo feature as a trigger for laboratory blood draws and PVi to inform fluid administration decisions in addition to hospital standard of care procedures. In vivo SpHb and PVi Monitoring: Pulse oximeter finger sensor that simultaneously monitors noninvasive hemoglobin (SpHb) and pleth variability index (PVi)	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=10 Participants	0 Participants n=10 Participants	29 Participants n=20 Participants
Age, Categorical >=65 years	14 Participants n=10 Participants	0 Participants n=10 Participants	14 Participants n=20 Participants
Sex: Female, Male Female	22 Participants n=10 Participants	0 Participants n=10 Participants	22 Participants n=20 Participants
Sex: Female, Male Male	21 Participants n=10 Participants	0 Participants n=10 Participants	21 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=10 Participants	0 Participants n=10 Participants	9 Participants n=20 Participants
Race/Ethnicity, Customized Hispanic, Latino, or Spanish origin	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Race/Ethnicity, Customized White or Caucasian	32 Participants n=10 Participants	0 Participants n=10 Participants	32 Participants n=20 Participants
Region of Enrollment United States	43 participants n=10 Participants	—	43 participants n=20 Participants

PRIMARY outcome

Timeframe: Approximately 6-8 hours

Population: Only historical chart review was able to be completed for the 43 control subjects, therefore there are no results to report for the control group. This study was not able to meet the enrollment target for the control and intervention groups, and therefore average volume of allogenic RBC transfused intra-operatively could not be defined (primary outcome measures).

Reduction in overall allogenic transfusion is defined as the decrease in volume of transfusion of the intervention group relative to control group, intra-operatively.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Evaluation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cristina Johnson

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60