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Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study

Not Applicable
Conditions
acute bronchiolitis
Registration Number
JPRN-UMIN000017792
Lead Sponsor
agano Children's Hospital Division of anesthesiology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who have severe congenital heart diseases. 2. Patients who has severe chronic lung disease. 3. Patients who have severe malformation of bronchi or lung. 4. Patients who are diagnosed as bronchial asthma and under treatment. 5. Patients who have severe physiologic conditions continued more than 6 hours as follows. 1) OI>15cmH2O/mmHg 2) Mean arterial pressure<30mmHg 3) Heart rate>200bpm 6. Patients who have to use medical devices with hot wire flow sensor (exclude the device which is confirmed with Heliox). 7. Patients who are predicted that need Heliox inhalation more than 7 days. 8. Other patients who are identified as inappropriate for this study by the physicians in charge.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare Length of PICU stay in Heliox group with historical control group. The criteria of PICU discharge is; SpO2 is more than 92% and clinically stable more than 6 hours under CPAP less than 10cmH2O and FIO2 less than 0.4.
Secondary Outcome Measures
NameTimeMethod
To compare Heliox group with historical control group. 1. Ventilation priod, CPAP priod, length of oxygen therapy, length of hospital stay, incidence rate of VAP, status of antibiotic usage. 2. To compare SpO2, EtCO2, PaO2, PaCO2, and tcPCO2 before Heliox administration with 15 minutes or 1 hour after Heliox administration .
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