Healthy, Surgery
Conditions
Brief summary
In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.
Interventions
DEVICERainbow DCI pulse oximeter sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers Inclusion Criteria: * Has physical status between ASA 1 or 2 * Able to communicate in English
Exclusion criteria
* Pregnant or sexually active without birth control. * Hemoglobin less than 11g/dL * Known alcohol or drug abuse * Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection * Nail polish * Head injury with loss of consciousness within the last year * Known neurological and psychiatric conditions. * Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs * Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Reynauds syndrome * Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg * Baseline heart rate \<50 beats per minute Surgical Subjects Inclusion Criteria: * Age \> 18 years old * Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | Up to 24 hours | Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
Rainbow DCI pulse oximeter sensor | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Test Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 90 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 90 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 72 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Accuracy of Sensor by Arms Calculation
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.
Time frame: Up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Group | Accuracy of Sensor by Arms Calculation | 0.9 g/dL |