Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients

KarmelSonix

Status: Unknown

Conditions: Asthma; Bronchiolitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01414322

KSI-IL-HHZ-ER-01

Details and patient eligibility

About

Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.

Enrollment: 45 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient is admitted to the ER with shortness of breath

• patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including:

  • asthma management protocol
  • bronchiolitis management protocol

• ages 0 - 15

• patient's parent/guardian is able to comprehend and give informed consent for participating in the study

Exclusion criteria

• patient has received any dose of inhaled bronchodilators in the hour prior to enrollment
• patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment
• ventilated patients, while ventilated
• chest skin lesions
• cystic fibrosis
• hemodynamic instability
• patient's parent/guardian objects to the study protocol
• concurrent participation in any other clinical study
• physician objection

Trial design

45 participants in 3 patient groups

Group 1: Patients ages 0 - 3

Group 2: Patients ages 3 - 7

Group 3: Patients ages 7 - 15