Digital Block
Conditions
Brief summary
This study will further investigate the Masimo SpHb \[FDA Approved\] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).
Detailed description
We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor. The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.
Interventions
DRUGLidocaine digital block
One dose of lidocaine 2% injected locally into one finger (2 mls total)
DEVICEMasimo SpHb continuous hemoglobin monitor
Masimo SpHb continuous hemoglobin monitor
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female 18 y/o or older * ASA Classification 1, 2 or 3 * Scheduled to undergo spine or hip revision surgery
Exclusion criteria
* Pregnant or nursing * Patients who in the study investigators clinical judgement would not be suitable for research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block. | A minimum of 2-4 differences recorded approximately hourly during surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Digital Block |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.
Time frame: A minimum of 2-4 differences recorded approximately hourly during surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Block (All Perfusion Indices 0.29-8.3) | 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 |
| Digital Block (All Perfusion Indices 0.29-8.3) | 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 |
| Digital Block (All Perfusion Indices 0.29-8.3) | 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 |
| Digital Block (All Perfusion Indices 0.29-8.3) | 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 |
| Digital Block (All Perfusion Indices 0.29-8.3) | 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 |
| Digital Block (Perfusion Indices >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. | >2.0 g/dL | 3 percentage of hemoglobin readings |
| Digital Block (Perfusion Indices >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 |
| Digital Block (Perfusion Indices >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. | 0.5-1.0 g/dL | 26 percentage of hemoglobin readings |
| Digital Block (Perfusion Indices >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. | 1.1-1.5 g/dL | 20 percentage of hemoglobin readings |
| Digital Block (Perfusion Indices >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. | 1.6-2.0 g/dL | 14 percentage of hemoglobin readings |