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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017792 |
Receipt No. | R000015392 |
Scientific Title | Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study |
Date of disclosure of the study information | 2015/06/03 |
Last modified on | 2015/06/03 |
Basic information | |||
Public title | Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study | ||
Acronym | Heliox inhalation therapy for pediatric severe acute bronchiolitis | ||
Scientific Title | Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study | ||
Scientific Title:Acronym | Heliox inhalation therapy for pediatric severe acute bronchiolitis | ||
Region |
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Condition | ||||
Condition | acute bronchiolitis | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate Heliox can shorten the PICU stay of Japanese pediatric patients with respiratory distress and/or respiratory failure associated with acute bronchiolitis. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase |
Assessment | |
Primary outcomes | 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. |
Key secondary outcomes | 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 . |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 1 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | 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. |
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Interventions/Control_2 | |||
Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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. |
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Key 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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagano Children's Hospital | ||||||
Division name | anesthesiology | ||||||
Zip code | |||||||
Address | 3100 Toyoshina, Azumino city, Nagano, Japan | ||||||
TEL | 0263-73-6700 | ||||||
seiki0623@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagano Children's Hospital | ||||||
Division name | anesthesiology | ||||||
Zip code | |||||||
Address | 3100 Toyoshina, Azumino city, Nagano, Japan | ||||||
TEL | 0263-73-6700 | ||||||
Homepage URL | |||||||
seiki0623@yahoo.co.jp |
Sponsor | |
Institute | Nagano Children's Hospital
Division of anesthesiology |
Institute | |
Department |
Funding Source | |
Organization | AIR WATER R&D CO., LTD. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Tokyo Metropolitan Children's medical center
Department of Pediatric Emergency & Critical Care Medicine |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 長野県立こども病院(長野県)、東京都立小児総合医療センター(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015392 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |