Phase 2 N=47 Randomized Quadruple-blind Treatment

Efficacy Study of a Facemask Device to Treat Hypotension

Hypotension

Bottom Line

View on ClinicalTrials.gov: NCT00256724 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline — 5.9; 12.9 mm Hg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Impedance Threshold Device (Device); sham ITD (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Advanced Circulatory Systems
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline	5.9; 12.9	—
SECONDARY Quantity of Fluid Administration	175; 93	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00256724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.