UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046280 |
|---|---|
| Receipt number | R000052745 |
| Scientific Title | Investigation of the optimal method of oxygen administration with simultaneous use of a surgical mask for patients after general anesthesia |
| Date of disclosure of the study information | 2021/12/06 |
| Last modified on | 2023/06/06 10:06:36 |
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Basic information
Public title
Investigation of the optimal method of oxygen administration with simultaneous use of a surgical mask for patients after general anesthesia
Acronym
Investigation of the optimal method of oxygen administration for patients after general anesthesia
Scientific Title
Investigation of the optimal method of oxygen administration with simultaneous use of a surgical mask for patients after general anesthesia
Scientific Title:Acronym
Investigation of the optimal method of oxygen administration for patients after general anesthesia
Region
| Japan |
Condition
Condition
Postoperative patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the optimal method of oxygen administration with simultaneous use of a surgical mask for patients after general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Partial pressure of arterial blood oxygen and partial pressure of arterial blood carbon dioxide five minutes after the change of oxygen administration method
Key secondary outcomes
Subjective evaluation of the comfort of each method
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Oxygen will be administered at 4 L/min for 5 min by Hudson mask over the surgical mask.
Interventions/Control_2
Oxygen will be administered at 4 L/min for 5 min by Hudson mask under the surgical mask
Interventions/Control_3
Oxygen will be administered at 4 L/min for 5 min by nasal cannula under the surgical mask.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent urological surgery who are scheduled to be admitted to the ICU
Persons who are legally competent to consent
Patients scheduled for arterial pressure measurement in intraoperative and postoperative management
Key exclusion criteria
Patients with a history of respiratory disease
Patients with an American Society of Anesthesiologists general status classification of 3 or higher
Patients who are judged by the physician to be unsuitable for participation in the study
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Saito |
Organization
Gunma University graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8454
shigerus@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Kamiyama |
Organization
Gunma University Hospital
Division name
Intensive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8698
Homepage URL
gun-tokue@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-7111
ciru_hitotaisho-irb@ml.gunma-u.ac.jp
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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
42
Results
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
| 2021 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052745
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
