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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017792
Enrollment
10
Registered
2015-06-03
Start date
2012-11-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute bronchiolitis

Interventions

To administer Heliox by a ventilator and/or a CPAP device. To continue to wean from ventilator and/or CPAP, or within 7 days whichever shorter.

Sponsors

Nagano Children's Hospital Division of anesthesiology
Lead Sponsor
Tokyo Metropolitan Children&#39
Collaborator
s medical center Department of Pediatric Emergency &amp
Collaborator
Critical Care Medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Less than 2 years old at the time of PICU admission. 2. On ventilator or CPAP. 3. the patients who are diagnosed to acute bronchiolitis Clinically (tachypnea, coughing, prolongation of expiratory time, expiratory stridor, moist rale and retraction), chest x-ray(with or without lung hyperinflation) and M-WCAS (more that 5). 4. Get informed consent from legal representative.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 .

Countries

Japan,Asia(except Japan)

Contacts

Public ContactSeiki Abe

Nagano Children's Hospital anesthesiology

seiki0623@yahoo.co.jp0263-73-6700

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026