POCUS-PEAC to Reduce Femoral Arterial Blood Flow

Terminated

• Conditions: Hemorrhage

• Registration Number: NCT04745585
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the flow reduction for each compression technique	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.

Secondary Outcome Measures

Name	Time	Method
Subject pain evaluation	15 minutes	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.
Side effects	7 days	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).

Trial Locations

Locations (1)

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada