UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014431 |
|---|---|
| Receipt number | R000016727 |
| Scientific Title | The effects of humidified nasal high-flow therapy in patients undergoing spinal anesthesia |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/06/30 17:49:34 |
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Basic information
Public title
The effects of humidified nasal high-flow therapy in patients undergoing spinal anesthesia
Acronym
The effects of humidified nasal high-flow therapy in patients undergoing spinal anesthesia
Scientific Title
The effects of humidified nasal high-flow therapy in patients undergoing spinal anesthesia
Scientific Title:Acronym
The effects of humidified nasal high-flow therapy in patients undergoing spinal anesthesia
Region
| Japan |
Condition
Condition
Patients who are undergoing spinal anesthesia with blood oxygen saturation below 95%
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of humidified nasal high-flow oxygen therapy to the regular oxygen mask in patients undergoing spinal anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Hemodynamics, respiratory status, including blood oxygen saturation, and blood gas analysis if needed during the surgeries after the spinal anesthesia effects are stabilized
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Apply the regular oxygen mask during the surgeries after spinal anesthesia is stabilized
Interventions/Control_2
Apply the humidified nasal high-flow oxygen therapy during the surgeries after spinal anesthesia is stabilized
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Undergoing spinal anesthesia with blood oxygen saturation below 95%
2)Agreed to participate in this study
Key exclusion criteria
1)Refused to participate in this study
2) Judged as irrelevant object for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Tomioka |
Organization
Saitama Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
Address
8-3-33 Kamiochiai Chuo-ku, Saitama-city, Saitama
TEL
048-852-1111
ttomioka-ns@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Tomioka |
Organization
Saitama Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
Address
8-3-33 Kamiochiai Chuo-ku, Saitama-city, Saitama
TEL
048-852-1111
Homepage URL
ttomioka-ns@umin.ac.jp
Sponsor or person
Institute
Saitama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 07 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2014 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016727
