Hypotension
Conditions
Keywords
hypotension, hypovolemia, dehydration, sepsis, blood loss
Brief summary
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.
Detailed description
The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of \<95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.
Interventions
Active impedance threshold device
DEVICEsham ITD
sham impedance threshold device
Sponsors
United States Department of Defense
Advanced Circulatory Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Conscious patient * Systolic blood pressure \< 95 mmHg * Hypotension caused by blood loss, sepsis, or dehydration
Exclusion criteria
* Hypotension secondary to heart failure * Complaints of chest pain * History of heart failure * Complaints of shortness of breath
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline | every 2 minutes during 10 minutes of device use |
Secondary
| Measure | Time frame |
|---|---|
| Quantity of Fluid Administration | during 10 minutes of device use |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the emergency department based on age (18-85)and systolic blood pressure ≤95mmHg who were conscious and presumed to have hypotension due to hypoivolemia or relative hypovolemia (blood loss, dehydration, or sepsis).
Participants by arm
| Arm | Count |
|---|---|
| Sham ITD sham Impedance Threshold Device | 23 |
| Active ITD active impedance threshold device | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 5 |
| Overall Study | Protocol Violation | 3 | 3 |
Baseline characteristics
| Characteristic | Active ITD | Sham ITD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age Continuous | 46.8 years STANDARD_DEVIATION 17.3 | 51.6 years STANDARD_DEVIATION 11.8 | 49.1 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 24 participants | 23 participants | 47 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline
Time frame: every 2 minutes during 10 minutes of device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham ITD | Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline | 5.9 mm Hg | Standard Deviation 5.9 |
| Active ITD | Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline | 12.9 mm Hg | Standard Deviation 8.5 |
Secondary
Quantity of Fluid Administration
Time frame: during 10 minutes of device use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham ITD | Quantity of Fluid Administration | 175 mL | Standard Deviation 197 |
| Active ITD | Quantity of Fluid Administration | 93 mL | Standard Deviation 170 |