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

This study is currently recruiting participants.
Verified August 2016 by Soroka University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03037801
First Posted: January 31, 2017
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Soroka University Medical Center
  Purpose
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.

Condition Intervention
Bronchiolitis Device: Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Length of PICU Stay [ Time Frame: 10 days ]
  • Need for Invasive Ventilation Support [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • S/F ratio [ Time Frame: Baseline, 15, 30 and 150 minutes after intervention ]
    Pulse oximetry saturation/fraction of inspired oxygen

  • Prevention of lung atelectasis [ Time Frame: 10 days ]
    Per chest x-ray


Estimated Enrollment: 50
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Intrapulmonary Percussive Ventilation
15 minutes of IPV physiotherapy
Device: Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
IPV physiotherapy 3 times a day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bronchiolitis
  • PICU patients
  • Non Invasive Pressure Support Ventilation
  • Age < 24 months

Exclusion Criteria:

  • Age > 24 months
  • Invasive Ventilation
  • No parental consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037801


Contacts
Contact: Yuval Cavari, MD 972-504562280 cavari@bgu.ac.il

Locations
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel
Contact: Yuval Cavari, MD    972504562280    cavari@bgu.ac.il   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Yuval Cavari, MD Soroka UMC
  More Information

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT03037801     History of Changes
Other Study ID Numbers: SOR-0074-16 CTIL
First Submitted: January 29, 2017
First Posted: January 31, 2017
Last Update Posted: June 2, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections