UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029269 |
|---|---|
| Receipt number | R000033454 |
| Scientific Title | Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2022/10/02 12:02:11 |
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Basic information
Public title
Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Acronym
Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Scientific Title
Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Scientific Title:Acronym
Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
Gastrointestinal disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluating oxygen delivery to maintain the safeness of sedated patients during nasal endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
transdermal oxygen saturation duaring endoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
transnasal catheterization
Interventions/Control_2
cannula
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who undergo endoscopy under sdation
Key exclusion criteria
Patients who have permanent tracheostoma or serious respiratory tract, otolaryngology disorder
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ishii |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
1410022
Address
5-9-22 Higashigotanda Shinagawaku Tokyo
TEL
0334486111
meitokuso@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Ishii |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
1410022
Address
5-9-22 Higashigotanda Shinagawaku Tokyo
TEL
0334486111
Homepage URL
meitokuso@yahoo.co.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
none
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
NTT Medical Center Tokyo
Address
5-9-22 Higashigotanda Shinagawaku Tokyo
Tel
0334486111
meitokuso@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/journal/26924609
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/journal/26924609
Number of participants that the trial has enrolled
116
Results
Nasal catheterization is superior to conventional oxygen administration
Results date posted
| 2022 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adults undergoing sedation endoscopy. Nasal catheter group: 71 years old, male-female ratio: 62.1:37.9%; conventional method: 72 years old, male-female ratio: 74.1:25.9%. There was no significant difference.
Participant flow
Of the 116 patients, 58 were assigned to nasal catheterization and conventional technique.
Adverse events
No major adverse events were seen with nasal catheterization, whereas hypoxia was seen with conventional technique.
Outcome measures
Primary endpoint is the rate of desaturation, which indicated the peripheral transcutaneous oxygen saturation showed below 90% which indicated acute respiratory deterioration at any points during the procedures. Secondary concern is side its effects and safety placing single sided trans-nasal catheter or nasal catheter in each group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033454
