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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011928
Receipt No. 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

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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
Institute Kurashiki central hospital
Institute
Department

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
URL(English) https://upload.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


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