UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041220 |
|---|---|
| Receipt number | R000047075 |
| Scientific Title | short guidewire assisted nasogastric tube insertion in anesthetized intubated patients: A prospective randomized controlled study |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2021/05/11 09:40:42 |
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Basic information
Public title
esophageal short guidewire assisted nasogastric insertion
Acronym
short guidewire assisted nasogastric tube insertion
Scientific Title
short guidewire assisted nasogastric tube insertion in anesthetized intubated patients: A prospective randomized controlled study
Scientific Title:Acronym
short guidewire assisted nasogastric tube insertion
Region
| Japan |
Condition
Condition
adult patients presenting for abdominal surgery under general anesthesia with neuromuscular relaxation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine whether short guidewire assisted nasogastric tube insertion results in a higher success rate than in usual manner
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
success rate without assist device
Key secondary outcomes
whether nasogastric tube fully goes into the stomach
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
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
use a 10Fr suction catheter as a sheath of a short guidewire(60cm) as a means of guidewire assisted nasogastric tube insertion
Interventions/Control_2
use no assist device
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
adult patients presenting for abdominal surgery under general anesthesia with neuromuscular relaxation
Key exclusion criteria
patients with esophageal varices, nasal septal deviation, upper airway anomalies, and coagulopathy were excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi hospital
Division name
anesthesia department
Zip code
9480065
Address
3 chome minami , 32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
seijihida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi hospital
Division name
anesthesia department
Zip code
9480065
Address
3 chome minami , 32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
Homepage URL
seijihida@yahoo.co.jp
Sponsor or person
Institute
Niigata prefectural tokamachi hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata prefectural tokamachi 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
Niigata prefectural tokamachi hospital
Address
3 chome minami , 32-9, takada, tokamachi city, niigata prefecture
Tel
0257575566
seijihida@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
新潟県立十日町病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 27 | 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
40
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
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047075
