Trial Outcomes & Findings for Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department (NCT NCT01780350)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

During device use, up to 1 hour

Results posted on

2015-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ResQGARD ITD n=200 Participants 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.
Age, Continuous	56.8 years STANDARD_DEVIATION 18.2 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ResQGARD ITD n=200 Participants 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.
Change in Systolic Blood Pressure From Baseline (Before ITD Use)	17.9 mmHg Standard Deviation 20.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ResQGARD ITD n=200 Participants 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.
Tolerability easy	115 participants
Tolerability moderate	36 participants
Tolerability difficult	30 participants
Tolerability not answered	19 participants

Adverse Events

ResQGARD ITD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Wampler, PhD

University of Texas Health Science Center San Antonio

Phone: 210.567.7598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place