Unique ID issued by UMIN | UMIN000018832 |
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Receipt number | R000021785 |
Scientific Title | Lower limit of acceptable oxygen saturation for respiratory disease of children : a non-randomised prospective intervention study |
Date of disclosure of the study information | 2015/08/27 |
Last modified on | 2023/01/08 00:05:38 |
Lower limit of acceptable oxygen saturation for respiratory disease of children : a non-randomised prospective intervention study
Lower limit of acceptable oxygen saturation for respiratory disease of children : a non-randomised prospective intervention study
Lower limit of acceptable oxygen saturation for respiratory disease of children : a non-randomised prospective intervention study
Lower limit of acceptable oxygen saturation for respiratory disease of children : a non-randomised prospective intervention study
Japan |
Pneumonia, bronchitis, bronchiolitis, asthma
Pediatrics |
Others
NO
To evaluate the shortening of length of stay without any adverse events when we change the limit of acceptable oxygen saturation for children with respiratory disease , from 94% to 90%
Safety,Efficacy
Confirmatory
Phase III
Difference in the duration of hospitalization between the cases with an oxygen saturation limit of 94% and 90%
A) Duration of oxygen administration and the number of re-administrations
B) Severity score for each disease
C) Frequency of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Behavior,custom |
To change the limit of acceptable oxygen saturation from 94% to 90%.
Not applicable |
16 | years-old | > |
Male and Female
1.A patient diagnosed with the lower respiratory tract infection or asthma. 2.Aged less than 16 years at registration.
3.Inpatient status.
4.A case oral consent was obtained from patient's guardians.
1. Cyanotic heart disease present.
2. Receiving home oxygen therapy.
3. Patient aged less than 3 months old at registration.
4. History of tracheostomy.
5. Airway abnormality (eg. laryngomalacia, sleeping apnea syndrome) present.
6. Chromosomal aberration present
7. Neuromuscular disease present.
8. Immunodeficiency present.
9. Required ICU admission.
10. Patient considered inappropriate as participants by team physicians.
350
1st name | |
Middle name | |
Last name | Hiroshi Hataya |
Tokyo Metropolitan Children's Medical Center
General Pediatrics
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan.
042-300-5111
hiroshi_hataya@tmhp.jp
1st name | |
Middle name | |
Last name | Nao Takasugi |
Tokyo Metropolitan Children's Medical Center
General Pediatrics
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan.
042-300-5111
nao_takasugi@tmhp.jp
Tokyo Metropolitan Children's Medical Center
None
Self funding
NO
2015 | Year | 08 | Month | 27 | Day |
Unpublished
Completed
2015 | Year | 08 | Month | 26 | Day |
2015 | Year | 08 | Month | 27 | Day |
2015 | Year | 08 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2015 | Year | 08 | Month | 27 | Day |
2023 | Year | 01 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021785
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