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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024179 |
Receipt No. | R000027839 |
Scientific Title | Nasal high-flow oxygen therapy in critically ill patients |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2017/03/29 |
Basic information | ||
Public title | Nasal high-flow oxygen therapy in critically ill patients | |
Acronym | Nasal high-flow oxygen therapy in critically ill patients | |
Scientific Title | Nasal high-flow oxygen therapy in critically ill patients | |
Scientific Title:Acronym | Nasal high-flow oxygen therapy in critically ill patients | |
Region |
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Condition | |||||
Condition | respiratory failure in critically ill patients | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of the study is to determine clinical factors for the improvement in respiratory failure in the critically ill patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | ICU stay |
Key secondary outcomes | ICU Mortality
90-day Mortality |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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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 | Critically ill patients received nasal high-flow oxygen therapy for respiratory failure | |||
Key exclusion criteria | None | |||
Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku University | ||||||
Division name | Department of Anesthesiology and Perioperative Medicine | ||||||
Zip code | |||||||
Address | 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan | ||||||
TEL | 0227177321 | ||||||
sugino@ruby.ocn.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tohoku University | ||||||
Division name | Department of Anesthesiology and Perioperative Medicine | ||||||
Zip code | |||||||
Address | 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan | ||||||
TEL | 0227177321 | ||||||
Homepage URL | |||||||
sugino@ruby.ocn.ne.jp |
Sponsor | |
Institute | Tohoku University |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
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 |
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 | We found the significance of Glasgow Coma Scale after failure in high-flow oxygen therapy. The sequential use of non-invasive positive pressure ventilation in the patient with normal response can reduce the duration of ICU stay and mortality. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | We will assign 300 patients to the trial. |
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=R000027839 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |