Recruiting

Observational Study

Sponsor:

Deep Breeze

Code:

NCT01206621

Conditions

Dyspnea

Eligibility Criteria

Sex: All

Age: 41+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital admission.

The ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. The VRI technique may provide a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to pulmonary causes; thereby improving management and outcomes.

Conditions

Dyspnea

Study ID

NCT01206621

Start date

Aug, 2010

Status verified date

Sep, 2010

Completion date

Jun, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 41+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able and willing to provide Informed Consent;

->40 years of age;
  • Estimated Body Mass Index >19;
  • Patient presented to the emergency department with a chief complaint of acute dyspnea.

Exclusion Criteria:

  • Patients with obvious trauma or acute anxiety as a cause of dyspnea;
  • Patient has already received directed therapy in the ED and symptoms are remarkably improved;
  • Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing;
  • Intubated or mechanically ventilated;
  • Acute hemodynamic or ventilator instability requiring immediate resuscitation;
  • Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
  • Hirsutism.

Study Design

Enrollment

530 participants

Anticipated

Interventions and Outcome Measures

Arms

ED patients presenting with dyspnea

Primary outcome measure

  • Assess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc). [ Time Frame: Baseline testing at ED presentation ]

Central Contacts and Locations

Central contacts

Charles V. Pollack, MD

215-829-7549cvpollack@gmail.com

Locations

Christiana Care Health System

Recruiting

Newark, Delaware, United States, 19718

Contacts

Barbara Davis, RN, BSN

302-733-4189bdavis@christianacare.org.org

Principal Investigator:

Jason T. Nomura, MD

Lincoln Medical and Mental Health Center

Recruiting

Bronx, New York, United States, 10451

Contacts

Muhammad Waseem, MD

718-579-6010waseemm2001@hotmail.com

Principal Investigator:

Muhammad Waseem, MD

Mount Sinai School of Medicine

Recruiting

New York, New York, United States, 10029

Contacts

Janice Lam

212-824-8078Janice.Lam@mountsinai.org

Principal Investigator:

Denise Nassisi, MD

Metrohealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44122

Contacts

Julie Nichols, RN

216-957-6488jnichols@metrohealth.org

Principal Investigator:

Rita Cydulka, MD

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Charles Pollack

215-829-7549cvpollack@gmail.com

Principal Investigator:

Charles V Pollack, MD

More Information

Sponsor

Deep Breeze

Last update posted

May 13, 2011

Last verified

Sep, 2010

Keywords

  • dyspnea
  • COPD
  • CHF
  • asthma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Deep Breeze on 2011-05-13.