This trial is active, not recruiting.

Condition acute hypotension
Treatment resqgard itd
Phase phase 4
Sponsor Advanced Circulatory Systems
Start date April 2012
End date March 2013
Trial size 120 participants
Trial identifier NCT01780350, W81XWH-BAA-11-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

Blood pressure
time frame: During device use, up to 1 hour

Secondary Outcomes

time frame: Duration of device use, up to 1 hour

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Advanced Circulatory Systems.