NCT04745585

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

March 31, 2026

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

February 4, 2021

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 seconds

Secondary Outcomes (2)

  • Subject pain evaluation

    15 minutes

  • Side effects

    7 days

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

  • age 18 to 40 years old

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raoul Daoust, MD, MSc

    Universite de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

December 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

March 31, 2026

Record last verified: 2022-02

Locations