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Phase II clinical trial for the effectiveness and safety of AW-PD01 (helium / oxygen mixed gas) for respiratory failure in children and infants with airway stenotic lesions: Single facility single group open label intervention study

Phase II clinical trial for the effectiveness and safety of AW-PD01 (helium / oxygen mixed gas) for respiratory failure in children and infants with airway stenotic lesions: Single facility single group open label intervention study - Helium-Oxygen gas clinical trial for infant with obstructive airway disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025065
Enrollment
10
Registered
2016-12-01
Start date
2016-12-01
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

Respiratory failure, Bronchiolitis

Interventions

Heliox Air

Sponsors

Tokyo Metropolitan Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed with acute bronchiolitis due to clinical symptoms (tachypnea, cough, extension of expiration time, exhalation wheezing, rale sounds and increasing work of breathing ), chest X-ray (pulmonary hyperinflation) 2. Hospitalized patients in intensive care unit 3. Patients who receive mechanical ventilation 4. written informed consent is obtained from the parent

Exclusion criteria

Exclusion criteria: 1. With cyanotic heart disease 2. With chronic lung disease 3. Receiving a diagnosis of bronchial asthma 4. patients who are judged unsuitable as subjects of the examination by the attending doctor

Design outcomes

Primary

MeasureTime frame
Airway resistance

Secondary

MeasureTime frame
PaCO2, tidal volume, lung compliance, the product of PaCO2 and driving pressure, length of ICU stay, length of intubation, safety

Countries

Japan

Contacts

Public ContactKenji Morimoto

Tokyo Metropolitan Children's Medical Center Department of Crtical Care Medicine

kjas09100728@gmail.com042-300-5111

Outcome results

None listed

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