Clinical trial NCT03719872: Point of Care Ultrasound for Diagnosis of Abdominal Free Air
Official title: Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Free Air in Abdomen
Keywords: laparoscopic surgery
transabdominal ultrasound
Free air
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects drawn from population of surgical patients at UMassMemorial Medical center undergoing elective laparoscopic surgery.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for elective laparoscopic surgery
* Age 18 or greater

Exclusion Criteria:

* Age less than 18
* Pregnant
* unable to provide consent

Primary outcomes:
measure: Presence of Free Air Artifact on Ultrasound
timeFrame: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMASS MEDICAL SCHOOL
name: David Blehar, MD
role: PRINCIPAL_INVESTIGATOR
References: