UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
NCT Number: NCT03719872
This study evaluates the ability of ultrasound to identify intraperitoneal free air. The study will consist of blinded review of abdominal ultrasound images of patients before and after laparoscopic surgery, a procedure which results in the introduction of air into the peritoneal cavity.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Worcester, Massachusetts, 01655, United States
Free peritoneal air is a marker of potential intraabdominal catastrophe, reflecting perforation of a hollow viscous organ such as stomach or intestine. While definitively identified by computed tomography, this diagnostic test can be delayed. Presence of air beneath the diaphragm on an upright chest or abdominal radiograph can allow for faster diagnosis, but again can present limitations in terms of timing.
Bedside clinician performed ultrasound has become standard practice in emergency medicine and critical care settings. Traditionally, air is not conducive to diagnostic ultrasound, but the artifacts it creates can be used to give clues about certain conditions. Recently this artifact has been proposed as a means to identify free peritoneal air. Several small studies have shown promise for the technique, but further investigation is warranted.
In this study the investigators will generate a database of standardized abdominal ultrasound images in subjects undergoing laparoscopic surgery. During this surgery, the peritoneal cavity is intentionally insufflated with air. The majority of this is removed at the end of the case, but small volumes of air remain, as evidence by the presence of air on CT scan when performed shortly after surgery.
The investigators will obtain a standardized set of images preoperatively and post operatively which will then be reviewed in a blinded fashion by three expert reviewers, one each from radiology, surgery and emergency medicine, with data analysis to determine sensitivity and specificity of ultrasound for free air.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre-Operative Transabdominal Ultrasound evaluation of the right upper quadrant of the abdomen. Examination with be performed with low frequency curvilinear transducer and high frequency linear transducer at 5 standardized locations along the right costal margin followed by a 10 second sweep along the costal margin from the xyphoid process to the mid-axillary line
Post-Operative Transabdominal Ultrasound evaluation of the right upper quadrant of the abdomen. Examination with be performed with low frequency curvilinear transducer and high frequency linear transducer at 5 standardized locations along the right costal margin followed by a 10 second sweep along the costal margin from the xyphoid process to the mid-axillary line
Time frame: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.
Hyperechoic echo originating from peritoneal stripe
David Blehar
Other
Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04949659
Appendicitis, Appendicitis Acute
Zurich, Canton of Zurich, Switzerland
View Trial DetailsNCT07662538
Body Weight, Digestive System Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07632287
Digestive System Diseases, Laparoscopic Gynecological Surgery
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07601035
Biliary Tract Diseases, Cholelithiases
Rawalpindi, Punjab Province, Pakistan
View Trial Details