Use of High Frequency Chest Compression in Pediatric Status Asthmaticus - Full Text View

Purpose

Asthma is a disease resulting in mucus hypersecretion and airways obstruction. This causes difficulty breathing. The High Frequency Chest Compressor (HFCC) is a device that has been shown to decrease respiratory complications in individuals with severe disability who are unable to clear airway secretions. There is a lack of studies using this device in children with asthma. The device has been shown in a study to be safe in children with asthma. We propose that using this device in our pediatric patients hospitalized in the pediatric ICU with asthma will result in decreased pediatric ICU stay. We will also look at asthma severity, total days of hospital stay and chest discomfort while on therapy.

Condition	Intervention
Status Asthmaticus, Pediatric	Device: High Frequency Chest Compression VEST

MedlinePlus related topics:

Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Official Title:	Use of High Frequency Chest Compression (HFCC) in Pediatric Status Asthmaticus

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

PICU stay [ Time Frame: days/hours ]

Secondary Outcome Measures:

asthma severity, hospital stay, chest discomfort [ Time Frame: scoring numbers, days/hours, yes/no - respectively ]

Estimated Enrollment:	37
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Experimental Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received	Device: High Frequency Chest Compression VEST every 6 hours for 20 minutes
2: No Intervention This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

2 to 21 yo (VEST approved for over two yo) Admitted to PICU for status asthmaticus Negative urine pregnancy test prior to initiation of study in those with menses

Exclusion Criteria:

Absolute contraindication to VEST use:
1. Unstable head or neck injury
2. Active hemorrhage with hemodynamic instability
3. Intracranial pressure > 20 mmHg or those in whom intracranial pressures should be avoided (was a relative contraindication but after discussion moved to absolute)

Presence of anomalies such as:

Former premature infant with BPD
Congenital bronchogenic or pulmonary anomaly (i.e. CF)
Congenital heart disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552448

Contacts


Contact: Adaobi C Kanu, MD	631 444 8340	akanu@notes.cc.sunysb.edu

Contact: Kimberly Tafuri, MD	631 444 2710	ktafuri@notes.cc.sunysb.edu

Locations


United States, New York
	Stony Brook University Medical Center	Recruiting
	Stony Brook, New York, United States, 11794

Sponsors and Collaborators

Stony Brook University

Investigators


Principal Investigator:	Adaobi C Kanu	Stony Brook University Hospital

More Information

Study ID Numbers:	20076812
First Received:	November 1, 2007
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00552448
Health Authority:	United States: Institutional Review Board

Keywords provided by Stony Brook University:

Pediatric, asthma, pediatric ICU

Study placed in the following topic categories:

Hypersensitivity

Respiratory Tract Diseases

Status Asthmaticus

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Bronchial Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Stony Brook University
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00552448