Free Air in AbdomenNCT03719872
Point of Care Ultrasound for Diagnosis of Abdominal Free Air
An observational study of Free Air in Abdomen, run by David Blehar at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Free Air in Abdomen
- What is being tested?
- Pre-Operative Transabdominal Ultrasound and Post-Operative Transabdominal Ultrasound
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects drawn from population of surgical patients at UMassMemorial Medical center undergoing elective laparoscopic surgery.
Who may be able to join
- Subjects scheduled for elective laparoscopic surgery
- Age 18 or greater
Who cannot join
- Age less than 18
- Pregnant
- unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal 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.
Read the 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.
- Conditions
- Free Air in Abdomen
- Being tested
- Pre-Operative Transabdominal Ultrasound, Post-Operative Transabdominal Ultrasound
- Keywords
- laparoscopic surgery, transabdominal ultrasound, Free air
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Operative Transabdominal UltrasoundDiagnostic 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 UltrasoundDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing laparoscopy | Participants undergoing laparoscopic abdominal surgery with surgical insufflation receiving pre-operative transabdominal ultrasound and post-operative transabdominal ultrasound. Receives: Diagnostic Test: Pre-Operative Transabdominal Ultrasound; Diagnostic Test: Post-Operative Transabdominal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Free Air Artifact on Ultrasound
Hyperechoic echo originating from peritoneal stripe
Measured: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Air in AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Blehar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Blehar, University of Massachusetts, Worcester
- Investigators
- David Blehar, MD, Principal investigator, UMASS MEDICAL SCHOOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719872
- Sponsor's protocol ID
- H-00013680
- Status last verified
- Nov 2019
- First submitted
- 19 Oct 2018
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air
- ClinicalTrials.gov ID
- NCT03719872
- Acronym / sponsor ID
- H-00013680
- Conditions
- Free Air in Abdomen
- Keywords
- laparoscopic surgery, transabdominal ultrasound, Free air
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- David BleharUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing laparoscopy | – | Diagnostic Test: Pre-Operative Transabdominal Ultrasound, Diagnostic Test: Post-Operative Transabdominal UltrasoundParticipants undergoing laparoscopic abdominal surgery with surgical insufflation receiving pre-operative transabdominal ultrasound and post-operative transabdominal ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects drawn from population of surgical patients at UMassMemorial Medical center undergoing elective laparoscopic surgery.
Key inclusion criteria (2 listed)
- Subjects scheduled for elective laparoscopic surgery
- Age 18 or greater
Key exclusion criteria (3 listed)
- Age less than 18
- Pregnant
- unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Operative Transabdominal UltrasoundPre-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 | Diagnostic test | Participants undergoing laparoscopy |
| Post-Operative Transabdominal UltrasoundPost-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 | Diagnostic test | Participants undergoing laparoscopy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Blehar, MD principal investigator
UMASS MEDICAL SCHOOL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Free Air in Abdomen, run by David Blehar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Free Air Artifact on Ultrasound (time frame: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.