Healthy VolunteersNCT06955013
Ultrasound to View Abdominal Wall Muscle Layers
An observational study of Healthy Volunteers, run by Corewell Health South at 1 site in United States.
Trial summary
The American College of Emergency Physicians (ACEP) views ultrasound-guided nerve blocks to be a core skill for emergency medicine physicians. They are used widely, commonly for various traumatic injuries, both for repair/stabilization of injuries, as well as for pain control while awaiting definitive management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult patients aged 18 and over who visit an academic community emergency department (ED) with an annual volume of approximately 69,000 patients. These patients are approached by emergency medicine residents during their ultrasound rotation and are asked to participate in the study.
Who may be able to join
- Age: Adult patients aged 18 and over
- Willingness to participate: Patients who are willing to undergo the ultrasound procedure and provide written informed consent
Who cannot join
- Age: Pediatric patients (under 18 years old)
- Consent: Patients unable to sign consent for themselves, including non-English speakers, patients with dementia or altered mental status
- At-Risk Populations: Pregnant patients, prisoners, and minors
- Infectious Considerations: Patients under isolation precautions or with open wounds/skin injury in the abdominal/flank area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corewell Health Lakeland
Saint Joseph, Michigan, 49085
About this study
Official title: Ability of Emergency Medicine Doctors to Use Ultrasound to View Muscle Layers of the Abdominal Wall
The American College of Emergency Physicians (ACEP) views ultrasound-guided nerve blocks to be a core skill for emergency medicine physicians. They are used widely, commonly for various traumatic injuries, both for repair/stabilization of injuries, as well as for pain control while awaiting definitive management. Ultrasound is often used to identify specific nerves or fascial planes to guide deposition of local anesthetic. Some of these blocks include interscalene brachial plexus blocks to help manage shoulder dislocation, supraclavicular brachial plexus nerve blocks to help manage elbow dislocation or distal wrist fracture reductions, fascia iliaca plane block for pain control of hip fractures patients awaiting definitive surgery, and serratus anterior plane block to help manage rib fracture pain. As these techniques become more mainstream due to increasing focus upon them in residency training and improvements in ultrasound technology, research upon these blocks has increased dramatically since 2016, with most of these articles focusing on hip fracture and shoulder dislocation.
The abdominal musculature of the flank is comprised of the external oblique muscle, internal oblique muscle, and the transversus abdominis. Branches of the lateral cutaneous nerve pass between the internal oblique muscle innervating the peritoneum. First described in the anesthesia literature in 2001, transversus abdominis plane (TAP) block has been found to decrease narcotic requirement after abdominal surgery by targeting these branches. It has also been found to be effective when performed by surgeons. However, it has been only minimally alluded to in the emergency medicine literature.
Read more
Obesity can have a negative effect on image procurement in ultrasound. Given how little TAP blocks have been reviewed in the emergency medicine literature, even less is known about emergency physicians' ability to deal with added difficulties brought by increases in body habitus. Some anesthesia teachers recommend out-of-plane needle approaches in obese patients rather than in-plane needle approaches for less challenging body habituses. Ultrasound-guided TAP blocks have been used successfully in bariatric surgery, so there is precedent for use in this population.
The study proposes to evaluate emergency medicine physician ability to obtain images suitable for potential TAP block administration in patients with varying body habitus. The hypothesis is that while potential TAP block could be limited by increased body habitus, the majority of patients would still be able to potentially undergo the procedure.
Methods Approval for this study will be sought from the Lakeland IRB. This is a prospective study conducted at an academic community emergency department with a volume of about 69,000 annually. Patients were approached by emergency medicine residents on their ultrasound rotation with regards to willingness to participate in the study and written informed consent was obtained. Inclusion criteria were adult patients aged 18 and over who were willing to undergo the informal ultrasound looking to identify the muscular layers with enough definition that a TAP block could be carried out. No injection of medication was carried out in this study. Exclusion criteria included pediatric patients, patients unable to sign consent for themselves (including non-English speakers, patients with dementia or altered mental status), as well as populations potentially at risk (such as pregnant patients, prisoners, and minors). Patients with infectious considerations were excluded (such as those under isolation precautions or with open wounds/skin injury in the abdominal/flank area).
If patients were willing to participate, residents assigned patients a study number and recorded basic demographic information (age, sex, race, ethnicity, and Body Mass Index (BMI)). Residents then carried out the ultrasound starting with the linear array probe at the level of the umbilicus, fanning laterally to identify the rectus sheath and then the shared aponeurosis for the internal oblique and transversus abdominis muscle. The resulting image of the abdominal wall was then recorded, saved under the patient's study identification number, and saved digitally to the study folder maintained on hospital servers. Patients were only enrolled once. Patients were analyzed for differences in the rates of obtaining adequate images based on body habitus.
- Conditions
- Healthy Volunteers
- Keywords
- Ultrasound, Emergency Medicine, Abdominal Wall, Muscle Layers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer; BMI 29.9 and below | Not described | |
| Healthy volunteer; BMI 30 and above | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of success in obtaining adequate images
Measured: Up to one week after ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Hysell, Corewell Health South
- Investigators
- Matthew Hysell, Principal investigator, Corewell Health South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955013
- Sponsor's protocol ID
- CHLIRB#1659
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Emergency Medicine Doctors to Use Ultrasound to View Muscle Layers of the Abdominal Wall
- ClinicalTrials.gov ID
- NCT06955013
- Acronym / sponsor ID
- CHLIRB#1659
- Conditions
- Healthy Volunteers
- Keywords
- Ultrasound, Emergency Medicine, Abdominal Wall, Muscle Layers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2025 (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.
The American College of Emergency Physicians (ACEP) views ultrasound-guided nerve blocks to be a core skill for emergency medicine physicians. They are used widely, commonly for various traumatic injuries, both for repair/stabilization of injuries, as well as for pain control while awaiting definitive management. Ultrasound is often used to identify specific nerves or fascial planes to guide deposition of local anesthetic. Some of these blocks include interscalene brachial plexus blocks to help manage shoulder dislocation, supraclavicular brachial plexus nerve blocks to help manage elbow dislocation or distal wrist fracture reductions, fascia iliaca plane block for pain control of hip fractures patients awaiting definitive surgery, and serratus anterior plane block to help manage rib fracture pain. As these techniques become more mainstream due to increasing focus upon them in residency training and improvements in ultrasound technology, research upon these blocks has increased dramatically since 2016, with most of these articles focusing on hip fracture and shoulder dislocation.
The abdominal musculature of the flank is comprised of the external oblique muscle, internal oblique muscle, and the transversus abdominis. Branches of the lateral cutaneous nerve pass between the internal oblique muscle innervating the peritoneum. First described in the anesthesia literature in 2001, transversus abdominis plane (TAP) block has been found to decrease narcotic requirement after abdominal surgery by targeting these branches. It has also been found to be effective when performed by surgeons. However, it has been only minimally alluded to in the emergency medicine literature.
Obesity can have a negative effect on image procurement in ultrasound. Given how little TAP blocks have been reviewed in the emergency medicine literature, even less is known about emergency physicians' ability to deal with added difficulties brought by increases in body habitus. Some anesthesia teachers recommend out-of-plane needle approaches in obese patients rather than in-plane needle approaches for less challenging body habituses. Ultrasound-guided TAP blocks have been used successfully in bariatric surgery, so there is precedent for use in this population.
The study proposes to evaluate emergency medicine physician ability to obtain images suitable for potential TAP block administration in patients with varying body habitus. The hypothesis is that while potential TAP block could be limited by increased body habitus, the majority of patients would still be able to potentially undergo the procedure.
Methods Approval for this study will be sought from the Lakeland IRB. This is a prospective study conducted at an academic community emergency department with a volume of about 69,000 annually. Patients were approached by emergency medicine residents on their ultrasound rotation with regards to willingness to participate in the study and written informed consent was obtained. Inclusion criteria were adult patients aged 18 and over who were willing to undergo the informal ultrasound looking to identify the muscular layers with enough definition that a TAP block could be carried out. No injection of medication was carried out in this study. Exclusion criteria included pediatric patients, patients unable to sign consent for themselves (including non-English speakers, patients with dementia or altered mental status), as well as populations potentially at risk (such as pregnant patients, prisoners, and minors). Patients with infectious considerations were excluded (such as those under isolation precautions or with open wounds/skin injury in the abdominal/flank area).
If patients were willing to participate, residents assigned patients a study number and recorded basic demographic information (age, sex, race, ethnicity, and Body Mass Index (BMI)). Residents then carried out the ultrasound starting with the linear array probe at the level of the umbilicus, fanning laterally to identify the rectus sheath and then the shared aponeurosis for the internal oblique and transversus abdominis muscle. The resulting image of the abdominal wall was then recorded, saved under the patient's study identification number, and saved digitally to the study folder maintained on hospital servers. Patients were only enrolled once. Patients were analyzed for differences in the rates of obtaining adequate images based on body habitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer; BMI 29.9 and below | – | – |
| Healthy volunteer; BMI 30 and above | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 and over who visit an academic community emergency department (ED) with an annual volume of approximately 69,000 patients. These patients are approached by emergency medicine residents during their ultrasound rotation and are asked to participate in the study.
Key inclusion criteria (2 listed)
- Age: Adult patients aged 18 and over
- Willingness to participate: Patients who are willing to undergo the ultrasound procedure and provide written informed consent
Key exclusion criteria (4 listed)
- Age: Pediatric patients (under 18 years old)
- Consent: Patients unable to sign consent for themselves, including non-English speakers, patients with dementia or altered mental status
- At-Risk Populations: Pregnant patients, prisoners, and minors
- Infectious Considerations: Patients under isolation precautions or with open wounds/skin injury in the abdominal/flank area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rates of success in obtaining adequate images
Time frame: Up to one week after ultrasound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Matthew Hysell principal investigator
Corewell Health South
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 Healthy Volunteers, run by Corewell Health South 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 4 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda L Borchardt (920-342-5023, amanda.borchardt@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of success in obtaining adequate images (time frame: Up to one week after ultrasound). 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 17 Dec 2025.