UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043760 |
|---|---|
| Receipt number | R000049956 |
| Scientific Title | Comparison of the slit-type introducer and blind technique for insertion of Nasogastric tube in anesthetized patients: a randomized controlled trial |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/03/18 14:07:32 |
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Basic information
Public title
Comparison of the slit-type introducer and blind technique for insertion of Nasogastric tube in anesthetized patients: a randomized controlled trial
Acronym
Comparison of the slit-type introducer and blind technique for insertion of Nasogastric tube in anesthetized patients: a randomized controlled trial
Scientific Title
Comparison of the slit-type introducer and blind technique for insertion of Nasogastric tube in anesthetized patients: a randomized controlled trial
Scientific Title:Acronym
Comparison of the slit-type introducer and blind technique for insertion of Nasogastric tube in anesthetized patients: a randomized controlled trial
Region
| Japan |
Condition
Condition
The patients intubated under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the slit-type introducer for insertion of Nasogastric tube in anesthetized patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The first-attempt success rate of the nasogastric tube insertion.
Key secondary outcomes
The time required to insert the nasogastric tube.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Nasogastric tube insertion with the slit-tyqe introducer.
Interventions/Control_2
Nasogastric tube insertion with blined technique.
Interventions/Control_3
Nasogastric tube insertion with lateral neck pressure.
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
The patients intubated under general anestagia.
Key exclusion criteria
a) Patients with esophageal varices b) Patients with head and/or neck trauma c) Patients with esophageal obstruction d) Patients with a history of pathological epistaxis e) Patients after head and/or neck surgery f) Patients with infections
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Okuda |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Department of Anesthesiology
Zip code
343-0845
Address
2-1-50, Minamikoshigaya, Koshigaya-shi, Saitama-ken, 343-0845, Japan
TEL
048-965-1111
okuday@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Naoi |
| Middle name | |
| Last name | Tsurumachi |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Department of Anesthesiology
Zip code
343-0845
Address
2-1-50, Minamikoshigaya, Koshigaya-shi, Saitama-ken, 343-0845, Japan
TEL
048-965-1111
Homepage URL
naoi-t@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center
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
Department of Anesthesiology, Dokkyo Medical University Saitama Medical Center
Address
2-1-50, Minamikoshigaya, Koshigaya-shi, Saitama-ken, 343-0845, Japan
Tel
048-965-1111
naoi-t@dokkyomed.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 | 04 | 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
62
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 | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049956
