Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume

Completed

Conditions studied: Hemorrhage

In brief

This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI system. Healthy human subjects will undergo progressive reduction in central blood volume to the point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating, nausea, or dizziness) to validate the following hypotheses: The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does not require calibration or being placed during normal physiological conditions.

Key facts

Study ID

NCT01935427

Run by

Flashback Technologies

People needed

42

Starts

2013-09-01

Expected to finish

2013-12-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy nonsmoking normotensive (<140/90) males or females.
• Age 18 to 55 yr.
• Normal clinical results from a Medical History and Physical form DD 2807-1
• Military or civilian.
• Documentation of a negative pregnancy test within 24 hours prior to each study period, if necessary.
• Not obese, as defined by body mass index (BMI) < 30, unless individual is athletic (BMI may not be the best method of assessing obesity in athletic individuals). BMI is calculated as the weight in kilograms divided by the square of the height in meters.

You may not qualify if…

• (a) Age <18 and >55 years.
• Individuals taking prescription drugs, non-prescription drugs or herbal medicines known to alter autonomic function unless cleared by the Medical Screener.
• Subjects using prescription medications within 30 days before initiation of the experiments unless cleared by the Medical Screener.
• Subjects with a history of alcohol or drug abuse which inhibits the subject's ability to complete this study.
• Smokers.
• Subjects with signs of cardiovascular abnormalities (e.g., hypertension (> 140/90), autonomic dysfunction (Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension), fainting disorder, etc.).
• Subjects with respiratory illnesses (e.g., asthma, Chronic Obstructive Pulmonary Disease, Reactive Airway Disease, etc.).
• Subjects with a history of anaphylaxis.
• Subjects with allergies to medications not cleared by the Medical Screener. Individuals reporting a history of pre-syncopal/syncopal episodes or orthostatic hypotension.
• Subjects with a history or family history of abnormal blood clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs.
• Individuals taking prescription medications for hypertension (high blood pressure). (l) Individuals with known or suspected abdominal hernias
• Pregnancy, trying to become pregnant, or breastfeeding

Where it is running

• US Army Institute of Surgical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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