N/A
N=93
Hemodilution Validation of INVSENSOR00026
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03677375 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation — 1.13 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INVSENSOR00026 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation |
1.13 | — |
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.
Eligibility 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
- 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.
- Subject is able to read and communicate in English and understands the study and risks involved.
Exclusion Criteria
- Subject is pregnant
- Subject smokes (including e-cigarette use)
- Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
- Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
- Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds.
- Subject has known drug or alcohol abuse or uses recreational drugs.
- Subject has experienced a head injury with loss of consciousness within the last year.
- Subject has taken anticoagulant medication within the last 30 days.
- Subject has any chronic bleeding disorders (i.e. hemophilia).
- Subject has any history of a stroke, myocardial infarction, heart attack, or seizures.
- Subject has any cancer or history of cancer (not including skin cancer).
- Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's disease).
- Subject has any cardiac dysrhythmias (i.e. atrial fibrillation) and has not received clearance from their physician.
- Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness.
- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome
- 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).
- Subject has taken opioid pain medication within 24 hours of start of study.
- Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
- Subject is taking medications known to treat any type of infectious disease.
- Subject has either signs or history of peripheral ischemia or carpal tunnel.
- 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.
- Subject has symptoms of congestion, head colds, flu, or other illnesses
- Subject has donated blood within the last 2 weeks.
- Subject is claustrophobic or has generalized anxiety disorder.
- Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
- Subject has had a concussion within the last 12 months.
- Subject has chronic unresolved asthma, lung disease or respiratory disease.
- Subject is allergic to lidocaine, latex, adhesives, or plastic.
- Subject has heart conditions, insulin-dependent diabetes or uncontrolled hypertension.
- Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
- 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 inv
Data sourced from ClinicalTrials.gov (NCT03677375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.