Unique ID issued by UMIN | UMIN000025065 |
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Receipt number | R000028837 |
Scientific Title | 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 |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2017/02/08 00:59:35 |
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
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
Japan |
Respiratory failure, Bronchiolitis
Pediatrics | Intensive care medicine |
Others
NO
Comparing the effectiveness and safety for respiratory failure in Japanese children / infants with obstructive airway disease between AW-PD01 (helium/oxygen mixed gas) therapy and existing therapy
Safety,Efficacy
Airway resistance
PaCO2, tidal volume, lung compliance, the product of PaCO2 and driving pressure, length of ICU stay, length of intubation, safety
Interventional
Cross-over
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Heliox
Air
0 | years-old | <= |
2 | years-old | > |
Male and Female
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
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
10
1st name | |
Middle name | |
Last name | Naoki Shimizu |
Tokyo Metropolitan Children's Medical Center
Department of Crtical Care Medicine
2-8-29, Musashidai, Fuchu city, Tokyo, Japan
042-300-5111
naoki_shimizu@me.com
1st name | |
Middle name | |
Last name | Kenji Morimoto |
Tokyo Metropolitan Children's Medical Center
Department of Crtical Care Medicine
2-8-29, Musashidai, Fuchu city, Tokyo, Japan
042-300-5111
kjas09100728@gmail.com
Tokyo Metropolitan Children's Medical Center
Center for Clinical Trials, Japan Medical Association
Non profit foundation
NO
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 11 | Month | 13 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 11 | Month | 30 | Day |
2017 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028837
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