POCUS-PEAC to Reduce Femoral Arterial Blood Flow

NCT ID: NCT04745585

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-02-01

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.

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• age 18 to 40 years old

Exclusion Criteria

• <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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Raoul Daoust

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raoul Daoust, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Universite de Montreal

Locations

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2020-1941

Identifier Type: -

Identifier Source: org_study_id