Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
9. juni 2014 opdateret af: Matthew T. Freedman, MD, Georgetown University
Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image. AP Stands for Antero-Posterior. PA Stands for Postero-anterior.
This is a study to determine whether or not a new type of software is, or is not, of benefit.
The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest.
These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer.
This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs.
The primary interest is in the time used to interpret the radiograph.
We will determine if there is any change in accuracy of detection.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis)
Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
10
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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District of Columbia
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Washington,, District of Columbia, Forenede Stater, 20007
- Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
There are two populations: the radiologists and the cases they will review.
For cases, these are sequential cases selected by database search using defined search criteria.
Beskrivelse
Inclusion Criteria:
- For the radiologists, they must in in active practice of community radiology (non-university sites).
- For the cases, they must be patients who have a tube, line, or wire in their chest. A small number of completely normal bedside chest radiographs will be included.
Exclusion Criteria:
- For radiologists: Not in active practice. Working in a university hospital.
- For cases: children. Do not meet image quality criteria.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Standard chest radiographs
The radiologists will be viewing two groups of chest images.
The first group are standard chest radiographs.
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Modified chest radiographs
This group of chest radiographs will be presented with the modified image.
The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time for Completion of Tasks
Tidsramme: 8 hours
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Time for completion of tasks of identifying the tips of tubes, lines, and wires.
Outlying values are excluded from the calculation of the mean values and standard errors.
Outlying values were defined as those more than three standard deviations from the mean time.
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8 hours
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Accuracy in Detecting the Tips of Tubes, Lines, and Wires.
Tidsramme: 8 hours
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Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel.
Measure is the distance from the median location determined by five experts in chest radiology.
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8 hours
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Likert-Like
Tidsramme: 10 minutes
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Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference.
On this scale, 1 indicates strong disagreement, 5 indicates strongly agree.
Ten statements were used.
Note that a low value for the standard image is equivalent to a high value for the modified image.
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10 minutes
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Matthew T Freedman, MD, MBA, Georgetown University
- Studieleder: Shih-Chung Ben Lo, Ph.D., Georgetown University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2012
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
30. juli 2012
Først indsendt, der opfyldte QC-kriterier
31. juli 2012
Først opslået (Skøn)
1. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MF 2012-1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .