UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016631
Receipt number R000018911
Scientific Title Efficacy of SUZY forceps for nasogastric tube insertion (randomized, clinical trial)
Date of disclosure of the study information 2015/02/25
Last modified on 2015/11/23 17:06:21

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Basic information

Public title

Efficacy of SUZY forceps for nasogastric tube insertion (randomized, clinical trial)

Acronym

Efficacy of SUZY forceps for nasogastric tube insertion

Scientific Title

Efficacy of SUZY forceps for nasogastric tube insertion (randomized, clinical trial)

Scientific Title:Acronym

Efficacy of SUZY forceps for nasogastric tube insertion

Region

Japan


Condition

Condition

diseases requiring gastrointestinal and hepato-biliary-pancreatic surgery

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate efficacy of SUZY forceps for nasogastric tube insertion under visual control by McGRATH MAC videolaryngoscope

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

time required for nasogastric tube insertion

Key secondary outcomes

success rate, frequencies and degrees of pharyngo-laryngeal complications, hemodynamic changes by nasogastric tube insertion


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

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

Device,equipment Maneuver

Interventions/Control_1

nasogastric tube insertion with SUZY forceps

Interventions/Control_2

nasogastric tube insertion with Magill forceps

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing gastro-intestinal, hepato-bilial-pancreatic surgery

Key exclusion criteria

patient's refusal, emergency case, a patient with full stomach, tracheostomy, predictable difficult airway, risk of hypoxia due to apnea less than 1 minute, risk of worsening of cardiovascular disease by hemodynamic change induced by McGRATH MAC, risk of hemorrhage due to upper gastrointestinal tract disease, abnormal teeth, pharyngo-laryngeal lesion, coagulopathy or low platelet counts, history of allergy and a case excluded by an attending anesthesiologist

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenta Furutani

Organization

Niigata University Medical and Dental Sciences

Division name

Anesthesiology

Zip code


Address

1-754, Asahimachi-Dori, Chuo-ku, Niigata

TEL

025-227-2328

Email

kenta-f@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenta Furutani

Organization

Niigata University Medical and Dental Sciences

Division name

Anesthesiology

Zip code


Address

1-754, Asahimachi-Dori, Chuo-ku, Niigata

TEL

025-227-2328

Homepage URL


Email

kenta-f@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata University

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


Address


Tel


Email



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

新潟大学医歯学総合病院


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 25 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

Completed

Date of protocol fixation

2015 Year 02 Month 02 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 25 Day

Last modified on

2015 Year 11 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018911


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name