Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
Solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.
The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.
Studieoversikt
Detaljert beskrivelse
Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.
In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Volunteer non-labouring pregnant women at term (≥ 36 weeks)-
- 18 years or older
- ASA Physical Status I-III
- 50-120 kg of weight
- 150 cm of height or taller
- Ability to understand the rationale of the study assessments and to provide signed informed consent
- Written informed consent
Exclusion Criteria:
- Known pre-existing abnormal anatomy of the upper gastrointestinal tract
- History of upper GI tract surgical procedure
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: empty stomach
No fluid will be given to the patient prior to scanning.
|
|
|
Eksperimentell: 50mL
50mL of water will be given to the patient prior to scanning
|
vann
|
|
Eksperimentell: 100mL
100mL of water will be given to the patient prior to scanning
|
vann
|
|
Eksperimentell: 200mL
200mL of water will be given to the patient prior to scanning
|
vann
|
|
Eksperimentell: 300mL
300mL of water will be given to the patient prior to scanning
|
vann
|
|
Eksperimentell: 400mL
400mL of water will be given to the patient prior to scanning
|
vann
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between ingested volume and CSA in antrum
Tidsramme: 5-10 minutes
|
The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.
|
5-10 minutes
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Cristian Arzola, MD, Mount Sinai Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13-07
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