- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01148732
Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation
21. juni 2010 opdateret af: National Taiwan University Hospital
Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill patients.
Incorrect placement causes a high rate of mortality and morbidity.
Therefore, early detection of accidental esophageal intubation must be a primary focus of emergency airway efforts in emergency department (ED).
Although many techniques have been suggested to verify the ETT placement, there is currently no entirely reliable method.
Ultrasonography (US) is an indispensable and easily accessible tool in ED.
Several studies of ultrasonographic confirmation of ETT position provided promising results in cadaver model or patient in a controlled operating room setting.In this study, the investigators have proposed a protocol called T.R.U.E, an acronym for tracheal rapid ultrasound exam, to confirm the ETT position in emergency intubation.
This method provided a fast, real-time examination to prevent esophageal or endotracheal intubation.
Studieoversigt
Detaljeret beskrivelse
Establishing a definite airway, endotracheal tube placement, is an important component for resuscitation.
A high rate of morbidity and mortality was reported for unrecognized esophageal intubation.
Therefore, early detection of esophageal intubation is essential for emergency airway management.
There are several methods being used for endotracheal tube confirmation, such as auscultation of breathing sound, chest X-ray and capnography.2
However, all of these methods had false-negative rates and not entirely reliable during resuscitation.
Ultrasound is an indispensable and easily accessible tool in emergency department.
Recent studies showed that ultrasound can be used to confirm endotracheal tube placement in cadaver model.
In this prospective study, we investigate the sensitivity and specificity of ultrasound for endotracheal tube confirmation in emergency intubation The study is conducted in the emergency department at National Taiwan University Hospital and approved by the hospital institutional review board.
During resuscitation, the duty emergency resuscitation team performs the intubation and confirms the endotracheal tube position by auscultation and end-tidal capnography.
Meanwhile, the researcher performs ultrasonography examinations for endotracheal tube position.
A curvilinear ultrasonography transducer is used and placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax.
The result of ultrasonography will be compared with auscultation, capnography and chest X-ray.
Sensitivity and specificity of ultrasonography examination is computed to determine the accuracy and effectiveness of clinical use.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan
- Rekruttering
- National Taiwan University Hospital
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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
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patient needed emergency intubation in emergency department
Beskrivelse
Inclusion Criteria:
- Patients required intubation
Exclusion Criteria:
- Head and Neck trauma
- Head and Neck tumor
- Status post tracheostomy
- Status post neck surgery
- Children (<18 years old)
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 |
Intervention / Behandling |
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Patient needed intubation in emergency department
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a Toshiba 3.75 MHz convex ultrasonography transducer (Toshiba SSA-550A, Tochigi-ken, Japan) was placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax by one of two emergency physician during emergency intubation investigators.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The endotracheal tube position
Tidsramme: 5 minutes
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We use ultrasound to confirm the endotracheal tube position in emergency intubation
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5 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time required for each assessment
Tidsramme: 1 hour
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Time required for ultrasonoraphy, capnography and chest X-ray
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1 hour
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Wan-Ching Lien, M.D, National Taiwan University Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. februar 2010
Primær færdiggørelse (Forventet)
1. februar 2011
Studieafslutning (Forventet)
1. februar 2011
Datoer for studieregistrering
Først indsendt
8. juni 2010
Først indsendt, der opfyldte QC-kriterier
21. juni 2010
Først opslået (Skøn)
22. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. juni 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2010
Sidst verificeret
1. juni 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201003027R
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 .
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