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Blind vs US Guided Manual Pressure Points

Primary Purpose

Junctional Hemorrhage, Extremity Hemorrhage

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual Pressure Point
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Junctional Hemorrhage focused on measuring Pressure Point, Junctional Hemorrhage

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion criteria: Age > 18 years. Combat pararescue medics who have completed their medics training course. Informed consent. Exclusion criteria: Any medical condition that causes or may cause discomfort during the experiment, including specifically conditions involving the groin, shoulder and neck. Any known vascular disease, including any known familial hypercoagulability disorder. Any known peripheral neuropathy. All of the above will be based on subjects' self-reporting. Subjects will be encouraged to consult with the unit's physician who will not be part of the study team but will be briefed about the study protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ultrasound guided

    Blind techniques

    Arm Description

    Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using an ultrasound probe visualizing the arteries, the underlying bones and the compression of the arteries.

    Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using the medic's hand based on anatomical land marks and palpation of pulse.

    Outcomes

    Primary Outcome Measures

    cumulative flow time
    The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.

    Secondary Outcome Measures

    cumulative flow
    A secondary outcome will be the calculated cumulative flow through the compressed point during each attempt

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Tel-Aviv Sourasky Medical Center
    Collaborators
    Israel Defense Forces
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06007209
    Brief Title
    Blind vs US Guided Manual Pressure Points
    Official Title
    Study Protocol: A Randomized Crossover Controlled Human Volunteer Trial Comparing Blind Manual vs. Ultrasound-guided Pressure Point in Combat Medics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 20, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center
    Collaborators
    Israel Defense Forces

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    the goal of this clinical trial is to compare the effectiveness of manual pressure points (femoral and supra-clavicular) for hemorrhage control by military medics using either the traditional blind manual technique or an ultrasound guided technique in healthy human volunteers. The main question to answer is which technique provides better results with regard to cumulative flow cessation during a 180 seconds attempt. Participants will press on each other's supraclavicular and femoral pressure points, twice each, once with an ultrasound probe and once with their hand, while distal flow is measured using ultrasound doppler.
    Detailed Description
    Each experimental day will include a maximum of 30 male subjects. Following the signing of an informed consent form and a questionnaire detailing possible exclusion criteria, subjects' demographics including age, gender, weight and height will be recorded. Right- or left-hand dominance, as well as the duration of service and previous training in MPP, will be determined by questioning and documented. This will be performed in a separate setting, ensuring subjects' privacy. Then, all participants will undergo hands-on training in small groups concerning the pressure point technique - both blind application and ultrasound-guided application of the technique. Each participant will have the opportunity to try each technique at least once at each point. Following the training session, participants will serve as both providers and models based on convenience (the order in which they approach the enrollment station), with each provider ideally becoming the subject for the next provider, although not necessarily. Each subject (medic) will perform two sets of attempts for pressure points application, on the same side of the model subject, which will be randomly determined (to avoid a bias created by the convenience of approach correseponding with providers' hand dominance). Before each set, the model subject's blood pressure and heart rate will be measured (on the contralateral side to the pressure application) and recorded. Each set will consist of three 180 seconds long attempts. Each attempt will be performed at a different point: Supraclavicular and femoral, with at least 120 seconds break between attempts. One of the sets will be performed using the blind, manual technique, using the provider's hands, and the other sets will be done using an ultrasound device guiding the location, direction and amount of pressure and using the probe itself to exert the pressure. The order in which the sets will be performed will be randomly determined. At any point, any of the subjects can stop and end the attempt due to discomfort or any other reason. His participation will cease immediately, without the need for an explanation or taking any steps on his part. In that case, the same attempt (e.g. blind supraclavicular pressure) will not be repeated. However, this will not preclude the subject from participating in the following attempts as long as he is willing to. At the end of each attempt, both the model and provider will be requested to rate their level of discomfort between 0 and 10 (NRS - Numerical Rating Score) During each attempt (including a 10-second baseline recording before each attempt), a sonographer will use a second ultrasound device to monitor blood flow distal to the pressure point using pulse-wave doppler. The sonographer will be blinded to the pressure technique used by the participant using a fabric blind and noise-cancelling headphones. The sonographer will vocally declare each time occlusion has been achieved or lost. A member of the experiment team will use a stopwatch to measure the total time of flow within each 180 seconds attempt. In addition, screen recording of the ultrasound device screen will be performed to allow for retrospective flow rate analysis using image analysis software. Screen recording of the pressing ultrasound screen will also be performed for potential retrospective analysis. Following each attempt, the cross-sectional area and mean flow rate of the artery in the intended pressure location will be measured by a sonographer to determine baseline flow through the artery, and clips will be collected to map the anatomy of the area for possible future analysis. This will be done after the attempt so that no markings will be left to guide the providers in their attempt.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Junctional Hemorrhage, Extremity Hemorrhage
    Keywords
    Pressure Point, Junctional Hemorrhage

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Sonographer will be masked from the pressure technique used with a fabric blind and noise-cancelling headphones.
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound guided
    Arm Type
    Active Comparator
    Arm Description
    Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using an ultrasound probe visualizing the arteries, the underlying bones and the compression of the arteries.
    Arm Title
    Blind techniques
    Arm Type
    Active Comparator
    Arm Description
    Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using the medic's hand based on anatomical land marks and palpation of pulse.
    Intervention Type
    Other
    Intervention Name(s)
    Manual Pressure Point
    Intervention Description
    Compression of the subclavian artery against the 1st rib and of the common femoral artery against the pelvis.
    Primary Outcome Measure Information:
    Title
    cumulative flow time
    Description
    The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.
    Time Frame
    180 seconds
    Secondary Outcome Measure Information:
    Title
    cumulative flow
    Description
    A secondary outcome will be the calculated cumulative flow through the compressed point during each attempt
    Time Frame
    180 seconds

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Age > 18 years. Combat pararescue medics who have completed their medics training course. Informed consent. Exclusion criteria: Any medical condition that causes or may cause discomfort during the experiment, including specifically conditions involving the groin, shoulder and neck. Any known vascular disease, including any known familial hypercoagulability disorder. Any known peripheral neuropathy. All of the above will be based on subjects' self-reporting. Subjects will be encouraged to consult with the unit's physician who will not be part of the study team but will be briefed about the study protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guy Avital, MD
    Phone
    972-52-8721517
    Email
    guy.avital.md.il@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ofer Almog, MD
    Email
    ofer18181@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guy Avital, MD
    Organizational Affiliation
    Israel Defense Forces
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ofer Almog, MD
    Organizational Affiliation
    Israel Defense Forces
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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