Ergonomics in the Cardiac Catheterization Laboratory

NCT06506968 | Recruiting

• 1 other identifier: 2023P000484
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to quantify ergonomic risk associated with traditional protective equipment in operators working in the cardiac catheterization laboratory as compared with a mobile protection system. The main questions it aims to answer is: What is the mean time spent by operators in positions of high ergonomic postural risk during cases? Participants will wear IMU, EMG, and radiation sensors, as well as complete baseline and discomfort surveys for several catheterization procedures.

Conditions

Ergonomics; Orthopedic Injury; Wellness

Keywords

Catheterization Laboratory; PCI; CTO; TAVR; Coronary Angiography

Outcome Measures

Primary Outcomes (1)

• Mean time spent in positions of high ergonomic risk

  This is a directly measurable endpoint utilizing the position and time data acquired from the IMU sensor system and this endpoint will be compared with and without the use of lead protective gear as well as across procedure category and physician reported case complexity. The investigators will report mean time spent in different ergonomic postures stratified by the Rapid Upper Limb Assessment scoring model (1-mild, 2-moderate, 3-high risk, 4-very high risk).

  May 2024 - December 2024

Secondary Outcomes (1)

• Mean self-reported musculoskeletal discomfort

  May 2024 - December 2024

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who will be recruited to this study include BWH staff who participate in cardiac catheterization laboratory procedures and consent to be in the study.

You may qualify if:

• Any member of the BWH cardiac catheterization laboratory who participates in procedures including:
• faculty interventional cardiologists and trainees
• general cardiology fellows
• residents
• physician assistants
• nurses
• circulating and monitoring technologists
• Physically able and willing to wear the sensors required for data collection in the study

You may not qualify if:

• Interventionalists not actively participating in the BWH Cardiac Catheterization Lab
• Not able or willing to wear the necessary sensors

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Rampart ic, LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Ajar Kochar

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajar Kochar

CONTACT

857-307-4000; akochar@bwh.harvard.edu

Raghav Gattani

CONTACT

rgattani@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director for Interventional Cardiology Fellowship

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 18, 2024
• Study Start: May 13, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)