- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03719872
Point of Care Ultrasound for Diagnosis of Abdominal Free Air
Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- UMASS Memorial Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects scheduled for elective laparoscopic surgery
- Age 18 or greater
Exclusion Criteria:
- Age less than 18
- Pregnant
- unable to provide consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants undergoing laparoscopy
Participants undergoing laparoscopic abdominal surgery with surgical insufflation receiving pre-operative transabdominal ultrasound and post-operative transabdominal ultrasound.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Free Air Artifact on Ultrasound
Time Frame: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.
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Hyperechoic echo originating from peritoneal stripe
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Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Blehar, MD, UMass Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-00013680
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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