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Trial record 28 of 36 for:    "Status Asthmaticus"

HFCWO in Hospitalized Asthmatic Children

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ClinicalTrials.gov Identifier: NCT00722020
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : November 24, 2015
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hill-Rom

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bronchial Asthma
Asthma
Status Asthmaticus
Intervention Device: VEST
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HFCWO / VEST Group Standard Care
Hide Arm/Group Description

Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.

High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest.

Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.

Regular nebulized bronchodilator treatment.: Sham Vest treatment.

Period Title: Overall Study
Started 19 24
Completed 19 24
Not Completed 0 0
Arm/Group Title HFCWO / VEST Standard Care With Sham Vest Total
Hide Arm/Group Description Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest. Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment. Total of all reporting groups
Overall Number of Baseline Participants 19 24 43
Hide Baseline Analysis Population Description
Pediatric patients admitted with diagnosis of Asthma
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 24 participants 43 participants
8.0  (2.3) 8.2  (2.0) 8.2  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 24 participants 43 participants
Female
10
  52.6%
10
  41.7%
20
  46.5%
Male
9
  47.4%
14
  58.3%
23
  53.5%
1.Primary Outcome
Title The Primary Endpoint Will be Time to Readiness for Discharge.
Hide Description Days in the hospital prior to patient being clinically ready to discharge
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
asthmatic children
Arm/Group Title HFCWO / VEST Group Standard Care
Hide Arm/Group Description:

Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.

High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest.

Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.

Regular nebulized bronchodilator treatment.: Sham Vest treatment.

Overall Number of Participants Analyzed 19 24
Mean (Standard Deviation)
Unit of Measure: days
1.74  (.7) 1.75  (.6)
2.Secondary Outcome
Title Secondary Endpoint Total Hospital Length of Stay
Hide Description Seconadary endpoint was Total Hospital length of stay
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HFCWO / VEST Standard Care With Sham Vest
Hide Arm/Group Description:
Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
Overall Number of Participants Analyzed 19 24
Mean (Standard Deviation)
Unit of Measure: days
2.5  (0.8) 2.5  (0.7)
Time Frame ICU admission and hospital admission time
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HFCWO / VEST Standard Care With Sham Vest
Hide Arm/Group Description Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest. Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
All-Cause Mortality
HFCWO / VEST Standard Care With Sham Vest
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HFCWO / VEST Standard Care With Sham Vest
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HFCWO / VEST Standard Care With Sham Vest
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jon Roberts, MD
Organization: Winthrop University
Phone: 516-663-4600
Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00722020     History of Changes
Other Study ID Numbers: CR-0078
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: August 25, 2015
Results First Posted: November 24, 2015
Last Update Posted: August 7, 2017