NCT03037801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 2, 2017

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

January 29, 2017

Last Update Submit

June 1, 2017

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (2)

  • Length of PICU Stay

    10 days

  • Need for Invasive Ventilation Support

    10 days

Secondary Outcomes (2)

  • S/F ratio

    Baseline, 15, 30 and 150 minutes after intervention

  • Prevention of lung atelectasis

    10 days

Study Arms (2)

Control

NO INTERVENTION

Intrapulmonary Percussive Ventilation

EXPERIMENTAL

15 minutes of IPV physiotherapy

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

Interventions

Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)DEVICE

IPV physiotherapy 3 times a day

Intrapulmonary Percussive Ventilation

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Yuval Cavari, MD

    Soroka UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Cavari, MD

CONTACT

972-504562280cavari@bgu.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2017

First Posted

January 31, 2017

Study Start

March 1, 2017

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

June 2, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)