- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02588495
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.
The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy volunteers aged 18 to 85 years
- Male or female
- American Society of Anesthesia physical status classification I and II
- Height greater than 145 cm
- Ability to understand the study protocol and provide informed consent
Exclusion Criteria:
- Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
- History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Fasting
Participant will remain fasted following initial gastric ultrasound
|
|
Eksperimentel: Food intake
Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound
|
Either drinking a cup of clear liquid, or having a cup of coffee and a muffin
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ultrasound's sensitivity to identify a "full stomach"
Tidsramme: 5 minutes
|
Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids
|
5 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ultrasound's accuracy in detecting a "full stomach"
Tidsramme: 5 minutes
|
Assessing how accurate the Ultrasound machine is in detecting either liquid or solid contents in the participant's stomach after ingestion
|
5 minutes
|
Inter/Intra-rater reliability of observer in detecting a "full stomach"
Tidsramme: 5 minutes
|
Determining the reliability of observers in being able to similarly detect a full stomach
|
5 minutes
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Anahi Perlas, MD, Staff Anesthesiologist
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 14-7883-BE
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 .
Kliniske forsøg med Forhåbning
-
Marshall UniversityAfsluttetBronkial aspirationForenede Stater
-
The University of Texas Health Science Center,...AfsluttetPulmonal aspirationForenede Stater
-
University of MalayaAfsluttetPulmonal aspirationMalaysia
-
University of CalgaryAlberta Health servicesIkke rekrutterer endnu
-
Ajou University School of MedicineAfsluttetGenerel anæstesi | Pulmonal aspirationKorea, Republikken
-
Zonguldak Bulent Ecevit UniversityAfsluttetSygeplejerskens rolle | Endotracheal aspirationKalkun
-
Azienda Ospedaliera Universitaria Integrata VeronaAktiv, ikke rekrutterendeEndoskopisk ultralyd | Fin-nål AspirationItalien
-
Vanderbilt UniversityAfsluttetAspiration, respiratoriskForenede Stater
-
Seoul National University HospitalAfsluttetEndobronchial Ultrasound Guided Transbronchial Needle AspirationKorea, Republikken
-
Ankara City Hospital BilkentAfsluttetAnæstesi | Børn, kun | Pulmonal aspiration | FasteKalkun
Kliniske forsøg med Food intake
-
Purdue UniversityAfsluttetJernmangel | A-vitamin mangelSenegal
-
Rutgers, The State University of New JerseyRekrutteringMiljøeksponering | Udvalg af madForenede Stater
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineUkendtErnæring | Mikrobiota | Supplerende madBangladesh
-
The Miriam HospitalNational Institute of General Medical Sciences (NIGMS)AfsluttetBetændelse | Fødevareusikkerhed | Fedme, barndom | Mentalt helbredForenede Stater
-
Centre Hospitalier Departemental VendeeAfsluttet
-
Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringDiabetes mellitus, type 2 | Dårlig ernæring | MadmangelForenede Stater
-
University of British ColumbiaAfsluttetHusholdningernes fødevaresikkerhedCambodja
-
NYU Langone HealthAmerican Heart AssociationRekruttering
-
Medical University of South CarolinaWW InternationalAfsluttetFedme | VægttabForenede Stater
-
Dartmouth-Hitchcock Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAktiv, ikke rekrutterende