Hemodilution Validation of INVSENSOR00026
Study Details
Study Description
Brief Summary
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. |
Device: INVSENSOR00026
Noninvasive pulse oximeter sensor
|
Outcome Measures
Primary Outcome Measures
- Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation [1-5 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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
-
Hemoglobin value is greater than or equal to 11 g/dL at time of screening
-
Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
-
CO value ≤ 2.0% FCOHb
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Subject has a physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
-
Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.
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Subject is able to read and communicate in English and understands the study and risks involved.
Exclusion Criteria:
-
Subject is pregnant
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Subject smokes (including e-cigarette use)
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Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
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Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
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Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds.
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Subject has known drug or alcohol abuse or uses recreational drugs.
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Subject has experienced a head injury with loss of consciousness within the last year.
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Subject has taken anticoagulant medication within the last 30 days.
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Subject has any chronic bleeding disorders (i.e. hemophilia).
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Subject has any history of a stroke, myocardial infarction, heart attack, or seizures.
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Subject has any cancer or history of cancer (not including skin cancer).
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Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's disease).
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Subject has any cardiac dysrhythmias (i.e. atrial fibrillation) and has not received clearance from their physician.
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Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness.
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Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome
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Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator).
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Subject has taken opioid pain medication within 24 hours of start of study.
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Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
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Subject is taking medications known to treat any type of infectious disease.
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Subject has either signs or history of peripheral ischemia or carpal tunnel.
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Subject has had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
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Subject has symptoms of congestion, head colds, flu, or other illnesses
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Subject has donated blood within the last 2 weeks.
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Subject is claustrophobic or has generalized anxiety disorder.
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Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
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Subject has had a concussion within the last 12 months.
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Subject has chronic unresolved asthma, lung disease or respiratory disease.
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Subject is allergic to lidocaine, latex, adhesives, or plastic.
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Subject has heart conditions, insulin-dependent diabetes or uncontrolled hypertension.
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Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
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Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
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Discretion of investigator/study staff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Masimo Corporation | Irvine | California | United States | 92618 |
Sponsors and Collaborators
- Masimo Corporation
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- TP-19466
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Protocol enrollment number includes screen failures and subjects that did not proceed due to time constraints |
| Arm/Group Title | Test Subject |
|---|---|
| Arm/Group Description | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor |
| Period Title: Overall Study | |
| STARTED | 93 |
| COMPLETED | 81 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | Test Subject |
|---|---|
| Arm/Group Description | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor |
| Overall Participants | 40 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
40
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
31
77.5%
|
| Male |
9
22.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian or Pacific Islander |
4
10%
|
| Caucasian |
15
37.5%
|
| Black or African American |
12
30%
|
| Hispanic |
9
22.5%
|
Outcome Measures
| Title | Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation |
|---|---|
| Description | 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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. |
| Time Frame | 1-5 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Test Subject |
|---|---|
| Arm/Group Description | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor |
| Measure Participants | 40 |
| Number [g/dL] |
1.13
|
Adverse Events
| Time Frame | 5 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Test Subject | |
| Arm/Group Description | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor | |
All Cause Mortality |
||
| Test Subject | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/93 (0%) | |
Serious Adverse Events |
||
| Test Subject | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/93 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Test Subject | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/93 (8.6%) | |
| Injury, poisoning and procedural complications | ||
| Swelling due to IV catheter site infiltration | 2/93 (2.2%) | |
| Vasovagal episode during arterial line placement | 1/93 (1.1%) | |
| Numbness secondary to local anesthetic infiltration | 1/93 (1.1%) | |
| Bruising and swelling at arterial site | 2/93 (2.2%) | |
| Headache | 1/93 (1.1%) | |
| Discomfort | 1/93 (1.1%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Tala Harake |
|---|---|
| Organization | Masimo |
| Phone | 9492977000 |
| studies@masimo.com |
- TP-19466