Phase II trial of helium / oxygen mixed gas for respiratory failure secondary to airway obstructive lesion in childre
- Conditions
- Respiratory failure due to airway obstructive lesion such as acute bronchiolitis, congenital tracheal stenosis, bronchial asthma attack
- Registration Number
- JPRN-jRCT2091220357
- Lead Sponsor
- Tokyo Metropolitan Children's Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of serious side effects caused by AW-PD01
- Secondary Outcome Measures
Name Time Method (1) Amount of change in the following items before and after administration of AW-PD01 <br>1.airway resistance value<br>2.Arterial blood carbon dioxide partial pressure (PaCO 2)<br>3.tidal volume<br>(2) Time from the start of administration of AW-PD01 until satisfying extubation criteria<br>(3) Time from the start of administration of AW-PD01 to extubation<br>(4) Time from the start of administration of AW-PD 01 to the intensive care room leaving time<br>(5) Adverse Event Expression Ratio at AW-PD01 Administration