Clinical trial NCT04745585: POCUS-PEAC to Reduce Femoral Arterial Blood Flow
Official title: External Compression of the Abdominal Aorta to Reduce Femoral Arterial Flow: Comparison Between the Manual Technique and the New Echo-guided Technique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemorrhage
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

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.

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

Primary outcomes:
measure: Comparison of the flow reduction for each compression technique
timeFrame: 20 seconds
Secondary outcomes:
measure: Subject pain evaluation
timeFrame: 15 minutes
measure: Side effects
timeFrame: 7 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
affiliation: Universite de Montreal
name: Raoul Daoust, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: