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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN82240782 |
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Date of registration:
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22/02/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Children receiving Heliox Inhalation in Croup: a randomised controlled trial
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Scientific title:
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Date of first enrolment:
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01/03/2007 |
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Target sample size:
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142 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN82240782 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Timothy
Coats |
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Address:
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Emergency Department
Leicester Royal Infirmary
Infirmary Square
LE1 5WW
Leicester
United Kingdom |
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Telephone:
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Email:
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tc61@le.ac.uk |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children, aged six months to five years, presenting to the Emergency Department (ED) with moderate to severe croup (Modified Westley Croup Score of two or more).
Exclusion criteria: 1. Children whose oxygen saturation is less than 95%
2. Children with known pre-existing lung or airway disease, congenital heart disease, or features suggesting other causes of stridor, such as peritonsillar abscess, epiglottitis or inhaled foreign body
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Croup (laryngotracheobronchitis)
Respiratory
Croup (laryngotracheobronchitis)
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Intervention(s)
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Patients will be randomly allocated to receiving ,additionally to the standard croup treatment, either Heliox21 (study group) or Air (control group). Comparison will be made of the primary and secondary outcome measures, comparing all those allocated to Heliox versus those allocated to Air.
29/11/2012: Please note that this trial was never started due to a lack of funding.
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Primary Outcome(s)
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Modified Westley Croup Score at 30 minutes
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Secondary Outcome(s)
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1. Croup score at 15 minutes
2. Respiratory rate at 15, 30 minutes
3. Parents assessment of change on Visual Analog Scale
4. Number of epinephrine nebulisers given
5. Requirement for supplemental oxygen therapy
6. Admission to hospital
7. Intubation rate
8. Length of stay in ED
9. Length of stay in hospital
10. Subsequent use of health services
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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