Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care ultrasound (POCUS). The pre-operative imaging will be done post-intubation and the post-operative imaging will be done pre-extubation. There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under general anesthesia at the time of imaging.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-85 years old
scheduled to undergo bariatric surgery
no prior abdominal surgery
Disqualifiers
ASA physical status > 3
Urgent or emergent surgery
Patient refusal or inability to consent
Prior abdominal surgery
Trial design
Design model
Single group
Treatments tested in this trial
Gastric Point of Care Ultrasound
Procedure/SurgeryAfter the patient has undergone intubation, the patient will be positioned in the supine and then the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient below the xiphoid process. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. After the images are obtained, the patient will be repositioned to supine for the procedure. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS prior to extubation.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Gastric Point of Care Ultrasound (POCUS) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in distance from peritoneal wall
Range: 3-5 cm. Higher score indicates greater displacement and less utility of gastric point-of-care ultrasound in these patients.
Time frame
end of the individual's procedure, at 2 hrs after procedure start on postoperative day 02
Gastric antrum Cross-sectional area (CSA)
Range: 1-10 centimeters squared. Gastric antrum Cross-sectional area (CSA) is a calculated product of Anteroposterior (AP) Diameter and Craniocaudal (CC) diameter. (CSA = AP x CC) Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
Time frame
end of the individual's procedure, at 2 hrs after procedure startSecondary outcomes
1
Anteroposterior (AP) Diameter
Range: 0-10 centimeters. Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
Time frame
end of the individual's procedure, at 2 hrs after procedure start2
Craniocaudal (CC) diameter
Range: 0-10 centimeters. Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.
Time frame
end of the individual's procedure, at 2 hrs after procedure start3
Postoperative aspiration events
Number of Postoperative aspiration events
Time frame
until day of hospital discharge, average 1-3 daysSponsors and contacts
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Source ClinicalTrials.gov
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