Point of Care Ultrasound for Diagnosis of Abdominal Free Air

Completed

• Conditions: Free Air in Abdomen
• Interventions: Diagnostic Test: Pre-Operative Transabdominal Ultrasound; Diagnostic Test: Post-Operative Transabdominal Ultrasound

• Registration Number: NCT03719872
• Lead Sponsor: David Blehar

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.

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2018-11-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants undergoing laparoscopy	Post-Operative Transabdominal Ultrasound	Participants undergoing laparoscopic abdominal surgery with surgical insufflation receiving pre-operative transabdominal ultrasound and post-operative transabdominal ultrasound.
Participants undergoing laparoscopy	Pre-Operative Transabdominal Ultrasound	Participants undergoing laparoscopic abdominal surgery with surgical insufflation receiving pre-operative transabdominal ultrasound and post-operative transabdominal ultrasound.

Primary Outcome Measures

Name	Time	Method
Presence of Free Air Artifact on Ultrasound	Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.	Hyperechoic echo originating from peritoneal stripe

Trial Locations

Locations (1)

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States