UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043280 |
|---|---|
| Receipt number | R000049139 |
| Scientific Title | The humidification performance of the heat and moisture exchanger in the long surgery, comparison between the high flow fresh gas group and the low flow fresh gas group |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2024/02/11 16:28:13 |
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Basic information
Public title
The humidification performance of the heat and moisture exchanger in the long surgery, comparison between the high flow fresh gas group and the low flow fresh gas group
Acronym
The humidification performance of the heat and moisture exchanger in the long surgery, comparison between the high flow fresh gas group and the low flow fresh gas group
Scientific Title
The humidification performance of the heat and moisture exchanger in the long surgery, comparison between the high flow fresh gas group and the low flow fresh gas group
Scientific Title:Acronym
The humidification performance of the heat and moisture exchanger in the long surgery, comparison between the high flow fresh gas group and the low flow fresh gas group
Region
| Japan |
Condition
Condition
Patients scheduled for general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the changes in intratracheal humidity caused by high-flow fresh gas during the long-term surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intratracheal humidity more than 2 hours after tracheal intubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
high flow fresh gas group(6l/min)
Interventions/Control_2
low flow fresh gas group(2l/min)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
general anesthesia with TIVA for more than 4 hours
Key exclusion criteria
respiratory disease
hypothermia
possibility of tracheal opening to the atmosphere such as a respiratory surgery and head and neck surgery
Patients with surgery that may cause a leak in the respiratory circuit, such as a tracheostomy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | Kajiura |
| Last name | Doshu |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
doshu.akira@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | Kajiura |
| Last name | Doshu |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
TEL
0339728111
Homepage URL
doshu.akira@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
Nihon University School of Medicine
Address
30-1, Oyaguchi, Kami-cho, Itabashi-ku, Tokyo, Japan
Tel
0339728111
doshu.akira@nihon-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049139
