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

June 1, 2017 updated by: Soroka University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Recruiting
        • Soroka Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age > 24 months
  • Invasive Ventilation
  • No parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of PICU Stay
Time Frame: 10 days
10 days
Need for Invasive Ventilation Support
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S/F ratio
Time Frame: Baseline, 15, 30 and 150 minutes after intervention
Pulse oximetry saturation/fraction of inspired oxygen
Baseline, 15, 30 and 150 minutes after intervention
Prevention of lung atelectasis
Time Frame: 10 days
Per chest x-ray
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Yuval Cavari, MD, Soroka UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

January 29, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR-0074-16 CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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