Blind Vs US Guided Manual Pressure Points

NCT06007209 | Active Not Recruiting

• 1 other identifier: 2375-2023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Junctional Hemorrhage; Extremity Hemorrhage

Keywords

Pressure Point, Junctional Hemorrhage

Outcome Measures

Primary Outcomes (1)

• cumulative flow time

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

  180 seconds

Secondary Outcomes (1)

• cumulative flow

  180 seconds

Study Arms (2)

Ultrasound guided

ACTIVE COMPARATOR

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.

Other: Manual Pressure Point

Blind techniques

ACTIVE COMPARATOR

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.

Other: Manual Pressure Point

Interventions

Manual Pressure Point OTHER

Compression of the subclavian artery against the 1st rib and of the common femoral artery against the pelvis.

Blind techniques; Ultrasound guided

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 years.
• Combat pararescue medics who have completed their medics training course.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Medical Corps, Israel Defense Force: collaborator

Study Sites (1)

Israel defense forces

Tel Aviv, Israel

Location

Study Officials

• Guy Avital, MD

  Israel Defense Forces

  STUDY DIRECTOR

• Ofer Almog, MD

  Israel Defense Forces

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sonographer will be masked from the pressure technique used with a fabric blind and noise-cancelling headphones.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tel-Aviv Sourasky Medical Center

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: August 20, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)