UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038000
Receipt number R000043319
Scientific Title The effects of shoulder roll on leak pressure and fiberoptic laryngeal view trough a supraglottic airway device, i-gel, for children
Date of disclosure of the study information 2019/09/12
Last modified on 2020/11/04 17:29:02

* 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

The effects of shoulder roll on leak pressure and fiberoptic laryngeal view trough a supraglottic airway device, i-gel, for children

Acronym

The effects of shoulder roll on leak pressure and fiberoptic laryngeal view trough a supraglottic airway device, i-gel, for children

Scientific Title

The effects of shoulder roll on leak pressure and fiberoptic laryngeal view trough a supraglottic airway device, i-gel, for children

Scientific Title:Acronym

The effects of shoulder roll on leak pressure and fiberoptic laryngeal view trough a supraglottic airway device, i-gel, for children

Region

Japan


Condition

Condition

pediatric surgery, plastic surgery

Classification by specialty

Surgery in general Anesthesiology Operative medicine
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the current study is to evaluate which i-gel position is better whether with/without shoulder roll. Accordingly, we investigated the leak pressure, and fiberoptic view of the epiglottis in the two positions when using the i-gel (size #2) in pediatric surgical patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

leak pressure

Key secondary outcomes

fiberoptic view


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

1 years-old <=

Age-upper limit

8 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients(10kg<bodyweight<20kg) were scheduled for elective surgery under general anesthesia without the need for intubation.

Key exclusion criteria

Exclusion criteria included the following: already intubated patient, patients with URI, anticipated airway difficulties, such as congenital malformation syndrome.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name JUN
Middle name
Last name YOSHINO

Organization

St. mary's Hospital

Division name

Department of Anesthesia

Zip code

830-8543

Address

422, Tsubukuhonmachi, Kurume, Fukuoka

TEL

0942-35-3322

Email

joooun@gmail.com


Public contact

Name of contact person

1st name YOSHIE
Middle name
Last name NAITOU

Organization

St. Mary's Hospital

Division name

Clinical, Educational and Reserch Devision

Zip code

830-8543

Address

422, Tsubukuhonmachi, Kurume, Fukuoka

TEL

0942-35-3322

Homepage URL


Email

naito-yoshie@st-mary-med.or.jp


Sponsor or person

Institute

Department of anesthesia, St. Mary's Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of anesthesia, St. Mary's 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

St. Mary's Hospital

Address

422, Tsubukuhonmachi, Kurume, Fukuoka

Tel

0942-35-3322

Email

kenkyusyo@st-mary-med.or.jpjoooun@gmail.com


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

聖マリア病院(福岡県)


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 12 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2019 Year 08 Month 22 Day

Date of IRB

2019 Year 09 Month 12 Day

Anticipated trial start date

2019 Year 09 Month 12 Day

Last follow-up date

2020 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The patients received general anesthesia using slow and stepwise inhalation of sevoflurane, from 3% to 8% with 100% oxygen with shoulder roll, followed by intravenous access. Lubricating jelly was used on the back of the i-gel. Size #2 i-gel was inserted when the end-tidal concentration of sevoflurane at 4% was achieved in each patient until some resistance was felt. The number of attempts at successful installation was recorded. The leak pressure, insertion depth defined as the distance between the incisor teeth and the tip of the device, and the fibreoptic glottis view through the proximal end of the device were simultaneously examined. A flexible fiber-optic scope with an outer diameter of 2.8 mm (Olympus Optical Co., Tokyo, Japan) connected to a video system was inserted through the i-gel to evaluate and record the anatomical position of the i-gel without shoulder roll.


Management information

Registered date

2019 Year 09 Month 12 Day

Last modified on

2020 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043319


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name