search
Back to results

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

Primary Purpose

Bronchiolitis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Soroka Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intrapulmonary Percussive Ventilation

Arm Description

15 minutes of IPV physiotherapy

Outcomes

Primary Outcome Measures

Length of PICU Stay
Need for Invasive Ventilation Support

Secondary Outcome Measures

S/F ratio
Pulse oximetry saturation/fraction of inspired oxygen
Prevention of lung atelectasis
Per chest x-ray

Full Information

First Posted
January 29, 2017
Last Updated
June 1, 2017
Sponsor
Soroka University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03037801
Brief Title
Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intrapulmonary Percussive Ventilation
Arm Type
Experimental
Arm Description
15 minutes of IPV physiotherapy
Intervention Type
Device
Intervention Name(s)
Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)
Intervention Description
IPV physiotherapy 3 times a day
Primary Outcome Measure Information:
Title
Length of PICU Stay
Time Frame
10 days
Title
Need for Invasive Ventilation Support
Time Frame
10 days
Secondary Outcome Measure Information:
Title
S/F ratio
Description
Pulse oximetry saturation/fraction of inspired oxygen
Time Frame
Baseline, 15, 30 and 150 minutes after intervention
Title
Prevention of lung atelectasis
Description
Per chest x-ray
Time Frame
10 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bronchiolitis PICU patients Non Invasive Pressure Support Ventilation Age < 24 months Exclusion Criteria: Age > 24 months Invasive Ventilation No parental consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Cavari, MD
Phone
972-504562280
Email
cavari@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Cavari, MD
Organizational Affiliation
Soroka UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Cavari, MD
Phone
972504562280
Email
cavari@bgu.ac.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs