Trial Outcomes & Findings for Comparison of Three Methods of Hemoglobin Monitoring (NCT NCT01284296)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

A minimum of 2-4 differences recorded approximately hourly during surgery

Results posted on

2012-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Digital Block The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Three Methods of Hemoglobin Monitoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Digital Block n=20 Participants The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: A minimum of 2-4 differences recorded approximately hourly during surgery

Outcome measures

Outcome measures
Measure	Digital Block (All Perfusion Indices 0.29-8.3) n=57 hemoglobin readings The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.	Digital Block (Perfusion Indices >2.0) n=35 hemoglobin readings The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss. This is a subgroup of differences with the perfusion index \>2.0
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. < 0.5 g/dL	37 percentage of hemoglobin readings	37 percentage of hemoglobin readings
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. 0.5-1.0 g/dL	19 percentage of hemoglobin readings	26 percentage of hemoglobin readings
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. >2.0 g/dL	9 percentage of hemoglobin readings	3 percentage of hemoglobin readings
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. 1.6-2.0 g/dL	17 percentage of hemoglobin readings	14 percentage of hemoglobin readings
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. 1.1-1.5 g/dL	18 percentage of hemoglobin readings	20 percentage of hemoglobin readings

Adverse Events

Digital Block

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

Ronald D. Miller

University of California, San Francisco

Phone: 415 476-9034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place