UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011928
Receipt number R000007385
Scientific Title Soft-tissue lateral neck radiographs to rule out acute epiglottitis: singlecentre, prospective patient collected observation study of diagnostic accuracy in adults
Date of disclosure of the study information 2013/10/01
Last modified on 2014/09/09 21:22:41

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Basic information

Public title

Soft-tissue lateral neck radiographs to rule out acute epiglottitis:
singlecentre, prospective patient collected observation study of diagnostic accuracy in adults

Acronym

Soft-tissue lateral neck radiographs to rule out acute epiglottitis

Scientific Title

Soft-tissue lateral neck radiographs to rule out acute epiglottitis:
singlecentre, prospective patient collected observation study of diagnostic accuracy in adults

Scientific Title:Acronym

Soft-tissue lateral neck radiographs to rule out acute epiglottitis

Region

Japan


Condition

Condition

acute epiglottitis

Classification by specialty

Infectious disease Oto-rhino-laryngology Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefullness of soft-tissue lateral neck radiographs to rule out acute epiglottitis:

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Presence of acute epiglottitis on radiograph.

Key secondary outcomes



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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who undergo lateral neck radiographs to detect supraglottitis

Key exclusion criteria

no consent, lost of follow

Target sample size

63


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujiwarabi

Organization

Kurashiki central hospital

Division name

Dept. Otorhinolaryngology/Head and Neck surgery

Zip code


Address

1-1-1 miwa, Kurashiki, Okayama, Japan

TEL

0864220210

Email

t.fujiwarabi@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Fujiwara

Organization

Kurashiki central hospital

Division name

Dept. Otorhinolaryngology/Head and Neck surgery

Zip code


Address

1-1-1 miwa, Kurashiki, Okayama, Japan

TEL

0864220210

Homepage URL


Email

t.fujiwarabi@gmail.com


Sponsor or person

Institute

Kurashiki central hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

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

倉敷中央病院(岡山県)


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://emj.bmj.com/content/early/2014/08/20/emermed-2013-203340.abstract

Number of participants that the trial has enrolled


Results

Results 140 patients had LNR during the study period. 35 patients were excluded from further analysis because of lack of consent. Of the 105 eligible patients, 21 patients (20%) were given the diagnosis of supraglottitis: 17 of 29 with a radiographic abnormality, and 4 of 76 patients without a radiographic abnormality. Three of the four cases where LNR was negative was grade 1, and all cases of grade 3 or higher had abnormal LNR. Sensitivity and specificity (95% CI) of LNR for supraglottitis were 81.0% (64.2 to 97.7) and 85.7% (78.2 to 93.2), respectively. The positive predictive value of LNR was 58.6% (40.7 to 76.5) and the negative predictive value was 94.7% (89.7 to 99.8). The positive likelihood ratio of LNR was 5.67 (3.27 to 9.82) and the negative likelihood ratio was 0.22 (0.10 to 0.51).

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

2011 Year 04 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 15 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry

2013 Year 08 Month 31 Day

Date trial data considered complete

2013 Year 08 Month 31 Day

Date analysis concluded

2013 Year 09 Month 15 Day


Other

Other related information

Design: A signle-centre prospective observational study in emergency department.
Setteing: Emergency department in Kurashiki central hospital, Japan
Participants: We prospectively evaluated adult patients who had taken LNR to detect supraglottitis.
Intervention: LNR to detect supraglottitis
Main outcome measures: Presence of supraglottitis using nasopharyngeal laryngoscopy or telephone call 7-30 day after the visit.


Management information

Registered date

2013 Year 10 Month 01 Day

Last modified on

2014 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007385


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name