Phase 2
Completed N=47
Efficacy Study of a Facemask Device to Treat Hypotension
Source: ClinicalTrials.gov NCT00256724 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline — 5.9; 12.9 mm Hg
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.
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 | — |
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
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. Informational only — not medical advice.