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Completed

NCT Number: NCT03719872

Point of Care Ultrasound for Diagnosis of Abdominal Free Air

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pre-Operative Transabdominal Ultrasound

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Presence of Free Air Artifact on Ultrasound

    Time frame: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.

    Hyperechoic echo originating from peritoneal stripe

Sponsors and collaborators

Lead sponsor

David Blehar

Other

Registry information

Official study title

Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Nov 6, 2019

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.

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