HemorrhageNCT04745585
POCUS-PEAC to Reduce Femoral Arterial Blood Flow
An observational study of Hemorrhage, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
The aim of this study is to evaluate the efficacy on healthy subjects of Point of Care ultrasonographically guided external aortic compression compared to the manual technique already described. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to 1 Feb 2021
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers
Who may be able to join
- age 18 to 40 years old
Who cannot join
- <18 years old, >40 years old, BMI <18 or >25, History of abdominal surgery, history of vascular surgery, known aortic disease, known peripheral vascular disease, coronary disease, smoking, history of smoking, diabetes, dislipidemia, arterial hypertension, abdominal or inguinal hernia, eating in the last 4 hours before intervention, abdominal pain on the day of intervention, abdominal bloating on the day of intervention, pregnancy, impossibility to visualize the aorta with the ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Compression of the Abdominal Aorta to Reduce Femoral Arterial Flow: Comparison Between the Manual Technique and the New Echo-guided Technique
The aim of this study is to evaluate the efficacy on healthy subjects of Point of Care ultrasonographically guided external aortic compression compared to the manual technique already described.
Read the detailed description
Manual Proximal External Aortic Compression (M-PEAC) has been described for temporizing non-compressible hemorrhage. Point of Care Ultrasonographically guided External Aortic Compression (POCUS-PEAC), a new technique, has been used for management of junctional hemorrhage. The aim of this study is to compare the efficacy of US-PEAC to M-PEAC in reducing the distal arterial flow. This study also evaluates whether a small weight operator would benefit most of the US-PEAC compared to a standard weight operator. Other objectives are to evaluate pain and secondary effects. We will conduct an experimental crossover trial on healthy volunteers. Subjects will be recruited using a convenient sample. M-EAC and US-EAC will be performed on each subject. Femoral arterial flows will be measured by Doppler before and after each compression. Femoral flow reduction will be calculated for each technique and compared. The compression will be first accomplished by an 80 kg operator followed by a 57 kg operator. After each compression, pain will be evaluated using a visual analog scale (VAS). Fifteen minutes after the intervention, pain will be recorded using the same VAS. A follow-up will be ensured at 24 hours and at one week to evaluate for secondary effects.
- Conditions
- Hemorrhage
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the flow reduction for each compression technique
For each subject, a nurse working at the vascular laboratory will measure the femoral arterial flow using Doppler ultrasound. A measurement will be noted before the interventions, after 20 seconds of manual compression, before the second intervention and after 20 seconds of POCUS compression. The reduction of flow will be calculated for each compression technique and the difference of reduction will be compared. The difference in flow reduction will also be compared for the small weight operator. The two operators will be blinded to the results.
Measured: 20 seconds
Secondary outcomes (2)
Subject pain evaluation
After each compression technique, the subject will be asked to evaluate the pain related to the intervention using a visual analogous scale (VAS)
Fifteen minutes after the completion of the intervention, they will be asked to reposition their residual discomfort on the VAS.
Measured: 15 minutes
Side effects
An assistant will call the subject at 24 hours following the intervention and at 7 days following the intervention to inquire about the presence of side effects (medical consultation, abdominal pain or other symptoms noted).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Dec 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Adverse event
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raoul Daoust, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Raoul Daoust, MD, MSc, Principal investigator, Universite de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745585
- Sponsor's protocol ID
- 2020-1941
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turcotte AS, Cournoyer A, Paquet J, Piette E, Zhu N, Bedard Michel W, Bilodeau L, Daoust R. Point-of-care ultrasound-guided external aortic compression compared to manual external aortic compression: a prospective crossover trial on healthy volunteers. CJEM. 2026 Jul;28(7):618-625. doi: 10.1007/s43678-026-01149-8. Epub 2026 Apr 27.
PubMed 42043775
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Compression of the Abdominal Aorta to Reduce Femoral Arterial Flow: Comparison Between the Manual Technique and the New Echo-guided Technique
- ClinicalTrials.gov ID
- NCT04745585
- Acronym / sponsor ID
- 2020-1941
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Adverse event
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 9 Feb 2021 (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 aim of this study is to evaluate the efficacy on healthy subjects of Point of Care ultrasonographically guided external aortic compression compared to the manual technique already described.
Detailed description
Manual Proximal External Aortic Compression (M-PEAC) has been described for temporizing non-compressible hemorrhage. Point of Care Ultrasonographically guided External Aortic Compression (POCUS-PEAC), a new technique, has been used for management of junctional hemorrhage. The aim of this study is to compare the efficacy of US-PEAC to M-PEAC in reducing the distal arterial flow. This study also evaluates whether a small weight operator would benefit most of the US-PEAC compared to a standard weight operator. Other objectives are to evaluate pain and secondary effects. We will conduct an experimental crossover trial on healthy volunteers. Subjects will be recruited using a convenient sample. M-EAC and US-EAC will be performed on each subject. Femoral arterial flows will be measured by Doppler before and after each compression. Femoral flow reduction will be calculated for each technique and compared. The compression will be first accomplished by an 80 kg operator followed by a 57 kg operator. After each compression, pain will be evaluated using a visual analog scale (VAS). Fifteen minutes after the intervention, pain will be recorded using the same VAS. A follow-up will be ensured at 24 hours and at one week to evaluate for secondary effects.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (1 listed)
- age 18 to 40 years old
Key exclusion criteria (1 listed)
- <18 years old, >40 years old, BMI <18 or >25, History of abdominal surgery, history of vascular surgery, known aortic disease, known peripheral vascular disease, coronary disease, smoking, history of smoking, diabetes, dislipidemia, arterial hypertension, abdominal or inguinal hernia, eating in the last 4 hours before intervention, abdominal pain on the day of intervention, abdominal bloating on the day of intervention, pregnancy, impossibility to visualize the aorta with the ultrasound
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
Comparison of the flow reduction for each compression technique
Time frame: 20 seconds
For each subject, a nurse working at the vascular laboratory will measure the femoral arterial flow using Doppler ultrasound. A measurement will be noted before the interventions, after 20 seconds of manual compression, before the second intervention and after 20 seconds of POCUS compression. The reduction of flow will be calculated for each compression technique and the difference of reduction will be compared. The difference in flow reduction will also be compared for the small weight operator. The two operators will be blinded to the results.
2 secondary outcomes
Subject pain evaluation
Time frame: 15 minutes
Side effects
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Adverse event). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 42043775Turcotte AS, Cournoyer A, Paquet J, Piette E, Zhu N, Bedard Michel W, Bilodeau L, Daoust R. Point-of-care ultrasound-guided external aortic compression compared to manual external aortic compression: a prospective crossover trial on healthy volunteers. CJEM. 2026 Jul;28(7):618-625. doi: 10.1007/s43678-026-01149-8. Epub 2026 Apr 27.
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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.
Raoul Daoust, MD, MSc principal investigator
Universite de Montreal
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 Hemorrhage, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 31 Mar 2026. 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 Canada. 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 was stopped early (reason given: Adverse event). Results are not available in the source record.
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?
Comparison of the flow reduction for each compression technique (time frame: 20 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745585, which also lists 1 linked publication.
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 31 Mar 2026.