Lower Body Negative Pressure to Validate Physiological Monitors
ConditionPhysiological Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMayo Clinic
About this trial
The purpose of this research is to test the accuracy of non-invasive physiological monitors while the body responds to different levels of lower body negative pressure (LBNP).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Non-obese (BMI<30)
Non-smokers
Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity.
Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test (within 48 hours of the study day)
Disqualifiers
Individuals taking GLP-1 medications or compounds known to affect responses of the autonomic nervous system to orthostatic stress (e.g., β-blockers)
Pregnant women
Trial design
Design model
Single group
Treatments tested in this trial
Lower Body Negative Pressure with Noninvasive Physiological Monitoring
Diagnostic testParticipants will undergo a graded lower body negative pressure protocol using suction levels of 15, 30, 45, 60, 70, 80, 90, and 100 mmHg, each for up to 5 minutes or until presyncopal symptoms or other termination criteria occur. During the procedure, validated reference physiological measurements and investigational noninvasive monitor signals will be collected simultaneously.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Healthy Volunteers Undergoing Lower Body Negative PressureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Arterial Oxygen Saturation During Lower Body Negative Pressure
Arterial oxygen saturation will be measured during lower body negative pressure using noninvasive physiological monitors
Time frame
During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes2
ECG Waveform During Lower Body Negative Pressure
ECG waveform will be measured during lower body negative pressure using noninvasive physiological monitor
Time frame
During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes3
Respiratory Rate During Lower Body Negative Pressure
Respiratory rate will be measured during lower body negative pressure using noninvasive physiological monitors
Time frame
During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes4
Plethysmography Signals During Lower Body Negative Pressure via physiological monitors
Plethysmography signals will be measured during lower body negative pressure from the pulse oximetry. Reported as a non-invasive research metric of central blood volume.
Time frame
During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov