UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017098
Receipt number R000019830
Scientific Title A comparison of the performance of supraglottic devices in children: a bayesian network meta-analysis
Date of disclosure of the study information 2015/04/10
Last modified on 2016/10/10 09:28:15

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Basic information

Public title

A comparison of the performance of supraglottic devices in children: a bayesian network meta-analysis

Acronym

A comparison of the performance of supraglottic devices in children: a bayesian network meta-analysis

Scientific Title

A comparison of the performance of supraglottic devices in children: a bayesian network meta-analysis

Scientific Title:Acronym

A comparison of the performance of supraglottic devices in children: a bayesian network meta-analysis

Region

Japan


Condition

Condition

Children who underwent general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this work was to conduct a network meta-analysis to compare the effectiveness and safety of supraglottic devices in children, and to compare and rank devices that have not been adequately compared in head-to-head trials.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

oropharyngeal leak pressure
insertion success/failure at the first attempt
blood staining on device

Key secondary outcomes

The post hoc secondary outcome is SGA failure.


Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit

18 years-old >

Gender

Male and Female

Key inclusion criteria

All randomized controlled trials that included a component comparing supraglottic devices in children who underwent general anaesthesia were included in this study. All type of laryngeal mask, laryngeal tube, i-gel, and air Q were considered supraglottic devices.

Key exclusion criteria

We excluded case reports, reviews, and animal studies. Eligibility was not restricted by language, type of surgery, or anaesthesia technique.

Target sample size

0


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Mihara

Organization

Kanagawa Childrens Medical Center

Division name

Department of Anesthesiology

Zip code


Address

Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan

TEL

045-711-2351

Email

miharaxxxtotoro@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Mihara

Organization

Kanagawa Childrens Medical Center

Division name

Department of Anesthesiology

Zip code


Address

Mutsukawa 2-138-4, Minami-ku, Yokohama, Japan

TEL

045-711-2351

Homepage URL


Email

miharaxxxtotoro@yahoo.co.jp


Sponsor or person

Institute

Kanagawa Childrens Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 10 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 04 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 02 Month 01 Day


Other

Other related information

This systematic review and meta-analysis of randomized controlled trials use MEDLINE, the Cochrane Central Register of Controlled Trials, Embase, the Web of Science, clinicaltrials.gov, the UMIN Clinical Trials Registry, and the references of identified papers.
Two authors independently assess all studies that were identified for potential inclusion as a result of the search. The full-text versions of potentially relevant studies chosen by at least one author are retrieved and evaluated, and those that meet the inclusion criteria are then assessed separately by two authors. Any discrepancies are resolved through discussion; if no agreement can be reached, a third author arbitrate.
Two authors extract the data independently from the included studies and then crosscheck the data. Disagreements are resolved by discussion between the two authors. If no agreement can be reached, a third author arbitrate.
The Bayesian network analysis was carried out modelling the outcome with the Bayesian hierarchical model using Markov chain Monte Carlo (MCMC) approach.


Management information

Registered date

2015 Year 04 Month 10 Day

Last modified on

2016 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019830


Research Plan
Registered date File name
2016/06/15 事前登録_研究計画詳細日本語.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name