An interventional study of Lower body negative pressure in Hypotension and Shock, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science
This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hypovolemia by analyzing the arterial waveforms collected during LBNP.
Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Inclusion criteria:
18-55 year of age Non-smoker No history of hypertension No history of diabetes No history of coronary artery disease No history of neurologic disease
Exclusion criteria Prescribed medications other than birth control Inability to lie flat for two hours BMI > 30 kg/m2
All volunteers will be studied at rest and during experimental condition (lower body negative pressure)
Other: Lower body negative pressure
Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
Blood pressure
Arterial blood pressure prior to and during lower body negative pressure
Time frame: One day of study visit
Heart rate
Heart rate prior to and during lower body negative pressure
Time frame: One day of study visit
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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