Acute Hypotension
Conditions
Brief summary
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.
Interventions
DEVICEResQGARD ITD
Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.
Sponsors
Advanced Circulatory Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults between the ages of 18-120 years * presenting to EMS with or development of Hypotension during EMS interaction * treated by EMS with the ITD
Exclusion criteria
* pediatric patients * patients that do not present with or develop hypotension * patients who the ITD will not form a secure seal due to anatomical abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline (Before ITD Use) | During device use, up to 1 hour | Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability | Duration of device use, up to 1 hour | Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ResQGARD ITD Subjects receive a ResQGARD ITD.
ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel. | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | ResQGARD ITD |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 18.2 |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
Primary
Change in Systolic Blood Pressure From Baseline (Before ITD Use)
Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.
Time frame: During device use, up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ResQGARD ITD | Change in Systolic Blood Pressure From Baseline (Before ITD Use) | 17.9 mmHg | Standard Deviation 20.9 |
Secondary
Tolerability
Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.
Time frame: Duration of device use, up to 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ResQGARD ITD | Tolerability | easy | 115 participants |
| ResQGARD ITD | Tolerability | moderate | 36 participants |
| ResQGARD ITD | Tolerability | difficult | 30 participants |
| ResQGARD ITD | Tolerability | not answered | 19 participants |