UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041220
Receipt No. 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 2020/07/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email seijihida@yahoo.co.jp

Sponsor
Institute Niigata prefectural tokamachi hospital
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2020 Year 12 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
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.