Phase II trial of helium / oxygen mixed gas for respiratory failure secondary to airway obstructive lesion in children

Phase II trial of helium / oxygen mixed gas for respiratory failure secondary to airway obstructive lesion in children - TMC-PI-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2091220357

Enrollment

Registered

2018-06-19

Start date

2018-07-01

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 due to airway obstructive lesion such as acute bronchiolitis, congenital tracheal stenosis, bronchial asthma attack

Interventions

Intervention type:DRUG Name of intervention:Helium / oxygen mixed gas inhalation therapy Dose form / Japanese Medical Device Nomenclature:INSUFFLATION Route of administration / Site of application:INH

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Those under 20 years old when registering cases (2) Patient who received one of the following diagnoses 1.acute bronchiolitis 2.congenital tracheal stenosis not undergoing radical surgery 3.bronchial asthma attack (3) Hospitalized in pediatric intensive care unit (4) Those wearing a ventilator under tracheal intubation or those clinically judged necessary for this treatment (5) Written informed consent from the guardian

Exclusion criteria

Exclusion criteria: (1) Patients with cyanosis heart disease (2) Patients with chronic lung disease (3) Patients who have current medical history, past history, etc. of liver diseases, kidney diseases, blood diseases, psychiatric / nervous system diseases requiring treatment and difficult to conduct clinical trial treatment (4) Patients diagnosed as chromosomal abnormalities (5) patients who is judged as inappropriate for this trial by investigators / clinical trial doctors

Design outcomes

Primary

Measure	Time frame
Ratio of serious side effects caused by AW-PD01	—

Secondary

Measure	Time frame
(1) Amount of change in the following items before and after administration of AW-PD01 1.airway resistance value 2.Arterial blood carbon dioxide partial pressure (PaCO 2) 3.tidal volume (2) Time from the start of administration of AW-PD01 until satisfying extubation criteria (3) Time from the start of administration of AW-PD01 to extubation (4) Time from the start of administration of AW-PD 01 to the intensive care room leaving time (5) Adverse Event Expression Ratio at AW-PD01 Administration	—

Measure

Time frame

(1) Amount of change in the following items before and after administration of AW-PD01 1.airway resistance value 2.Arterial blood carbon dioxide partial pressure (PaCO 2) 3.tidal volume (2) Time from the start of administration of AW-PD01 until satisfying extubation criteria (3) Time from the start of administration of AW-PD01 to extubation (4) Time from the start of administration of AW-PD 01 to the intensive care room leaving time (5) Adverse Event Expression Ratio at AW-PD01 Administration

—

Countries

Japan

Contacts

Public ContactYoshihiko Morikawa

Tokyo Metropolitan Children's Medical Center

morikawa@2005.jukuin.keio.ac.jp+81-42-300-5111

Outcome results

None listed

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