UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051009 |
|---|---|
| Receipt number | R000058149 |
| Scientific Title | A COMPARISON ABOUT HYPOXIA PREVENTIVENESS OF 2 PREOXYGENATION TECHNIQUES IN ANESTHETIC PRACTICE |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2023/05/08 21:20:46 |
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Basic information
Public title
A COMPARISON ABOUT HYPOXIA PREVENTIVENESS OF 2 PREOXYGENATION TECHNIQUES IN ANESTHETIC PRACTICE
Acronym
A COMPARISON ABOUT HYPOXIA PREVENTIVENESS OF 2 PREOXYGENATION TECHNIQUES IN ANESTHETIC PRACTICE
Scientific Title
A COMPARISON ABOUT HYPOXIA PREVENTIVENESS OF 2 PREOXYGENATION TECHNIQUES IN ANESTHETIC PRACTICE
Scientific Title:Acronym
A COMPARISON ABOUT HYPOXIA PREVENTIVENESS OF 2 PREOXYGENATION TECHNIQUES IN ANESTHETIC PRACTICE
Region
| Europe |
Condition
Condition
HEALTHY NONSMOKER MALE VOLUNTEERS WHO ARE ASA-I, WITHOUT A GENERAL ANESTHESIA HISTORY AND AGED BETWEEN 18-32
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
RESEARCHING THE TISSUE OXYGEN RESERVE EFFECTS OF 2 DIFFERENT PREOXYGENATION TECHNIQUES THAT IS USED FOR INTUBATION DIFFICULTIES IN ANESTHETIC PRACTICE
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
REACHED ORI LEVELS FOR BOTH 2 TECHNIQUES
Key secondary outcomes
DURATION NEEDED TO REACH TARGET ORI LEVEL (0.35) FOR BOTH TECHNIQUES
DURATION NEEDED TO REACH MAXIMUM ORI LEVEL FOR BOTH TECHNIQUES
DURATION NEEDED TO REACH BACK TO "0" LEVEL FOR ORI AFTER COMPLETING BOTH TECHNIQUES
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
FIRST TECHNIQUE IS TO APPLY VOLUNTEERS %100 FIO2 OXYGEN WITH 5 LT/MIN FLOW WITH A VENTILATION MASK DURING THEY BREATHE NORMALLY AS MUCH AS THEIR NORMAL TIDAL VOLUMES FOR 3 MINUTES, THEN AFTER WAITING UNTIL VOLUNTEERS RELAX COMPLETELY AS SECOND TECHNIQUE IS TO APPLY THEM %100 FIO2 OXYGEN WITH 10 LT/MIN FLOW WITH THE SAME MASK FOR AS MUCH AS 8 DEEP INSPIRATORY VOLUMES, WHICH IS ASSUMED TO BE COMPLETED IN ABOUT 1 MINUTE. MAXIMUM ORI LEVELS WERE MONITORED, DURATION TO REACH THAT LEVEL, DURATION NEEDED TO REACH TARGET ORI LEVEL (0.35) AND REACH BACK TO "0" LEVEL FOR ORI(WHICH REFERS A SAFE APNEA PERIOD DURING INTUBATION) AFTER COMPLETING THE TECHNIQUES WERE MEASURED AND COMPARED STATISTICALLY AND CLINICALLY.
Interventions/Control_2
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
| 32 | years-old | >= |
Gender
Male
Key inclusion criteria
HEALTHY NONSMOKER MALE VOLUNTEERS AGED BETWEEN 18-32, ASA-I AND WITHOUT GENERAL ANESTHESIA HISTORY
Key exclusion criteria
HAVING ANEMIA, BEING OUT OF NORMOTENSIVE BLOOD PRESSURE LIMITS, STAI ANXIETY LEVELS OVER 41
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | FATMA |
| Middle name | YESIM |
| Last name | ABUT |
Organization
ISTANBUL TRAINING AND RESEARCH HOSPITAL
Division name
ANESTHESIOLOGY AND REANIMATION CLINIC
Zip code
34098
Address
CERRAHPASA DISTRICT ORGENERAL NAFIZ GURMAN STREET NO:24
TEL
00905376812640
yesimabut2000@yahoo.com
Public contact
Name of contact person
| 1st name | ECE |
| Middle name | - |
| Last name | KISA |
Organization
ISTANBUL TRAINING AND RESEARCH HOSPITAL
Division name
ANESTHESIOLOGY AND REANIMATION CLINIC
Zip code
34098
Address
CERRAHPASA DISTRICT ORGENERAL NAFIZ GURMAN STREET NO:24
TEL
00905434228442
Homepage URL
ece.kisa94@gmail.com
Sponsor or person
Institute
ISTANBUL TRAINING AND RESEARCH HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
ISTANBUL TRAINING AND RESEARCH HOSPITAL
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
ISTANBUL TRAINING AND RESEARCH HOSPITAL
Address
CERRAHPASA DISTRICT ORGENERAL NAFIZ GURMAN STREET NO:24
Tel
00905434228442
ece.kisa94@gmail.com
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
| 2023 | Year | 05 | Month | 08 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2023 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058149
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| Registered date | File name |
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