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NCT03037801 Clinical Trial

Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support

Bronchiolitis Clinical Trial

Official title:
Prospective Randomized Controlled Study of the Use of Intrapulmonary Percussive Ventilation (IPV) for Children With Bronchiolitis Admitted to the Pediatric Intensive Care Unit (PICU) and Are on Non-Invasive Ventilation Support

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03037801
Other study ID # SOR-0074-16 CTIL
Secondary ID
Status Recruiting
Phase N/A
First received January 29, 2017
Last updated June 1, 2017
Start date March 1, 2017
Est. completion date July 2018

Study information
Verified date August 2016
Source Soroka University Medical Center
Contact Yuval Cavari, MD
Phone 972-504562280
Email cavari@bgu.ac.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. The patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using Intrapulmonary Percussive Ventilation.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date July 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria:

- Bronchiolitis

- PICU patients

- Non Invasive Pressure Support Ventilation

- Age < 24 months

Exclusion Criteria:

- Age > 24 months

- Invasive Ventilation

- No parental consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
IPV physiotherapy 3 times a day

Locations
Country Name City State
Israel Soroka Medical Center Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of PICU Stay 10 days
Primary Need for Invasive Ventilation Support 10 days
Secondary S/F ratio Pulse oximetry saturation/fraction of inspired oxygen Baseline, 15, 30 and 150 minutes after intervention
Secondary Prevention of lung atelectasis Per chest x-ray 10 days
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