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

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ClinicalTrials.gov Identifier: NCT03037801
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Device: Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
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




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

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

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



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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

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

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT03037801     History of Changes
Other Study ID Numbers: SOR-0074-16 CTIL
First Posted: January 31, 2017    Key Record Dates
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