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Efficacy Study of a Facemask Device to Treat Hypotension

NCT00256724 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2013-07-31

Study results available
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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.

Conditions

Interventions

DEVICE

Impedance Threshold Device

Active impedance threshold device

DEVICE

sham ITD

sham impedance threshold device

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Advanced Circulatory Systems

    lead INDUSTRY

Principal Investigators

  • Keith Lurie, MD · Advanced Circulatory Systems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00256724 on ClinicalTrials.gov