Point of Care Ultrasound for Diagnosis of Abdominal Free Air

Free Air in Abdomen Clinical Trial

Official title:

Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719872
• Other study ID #: H-00013680
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects scheduled for elective laparoscopic surgery

• Age 18 or greater

Exclusion Criteria:

• Age less than 18

• Pregnant

• unable to provide consent

Related Conditions & MeSH terms

• Free Air in Abdomen
• Pneumoperitoneum

Intervention

Diagnostic Test:
• Pre-Operative Transabdominal Ultrasound
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
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

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
David Blehar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Free Air Artifact on Ultrasound	Hyperechoic echo originating from peritoneal stripe	Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.