Workbench

HOBIT

Workbench

Welcome to the HOBIT Workbench (formerly toolbox). The workbench provides essential resources and guidelines for study teams, covering regulatory requirements, clinical procedures, informed consent, data management, training materials, and more. Click on the options below to explore the available resources.

Would you like a resource on this page that isn’t here? Please use the “submit a workbench request” button!

Chamber and Subject Log v.9 

Multiplace Readiness Checklist 

HBO Checklist 

Magellan Ventilator: 

Hyperbaric Safety Pause Checklist Revision 2

Example of Laminated Card – NBH x 4.5 

Example of laminated cards that identify the treatment group, along with start and stop times. These can be placed in and around the chamber room.

Example of Laminated Card

 Post HBO 3hrs NBH – Example of laminated cards for NBH group. Study teams can affix these cards to the ventilator and be marked with dry erase markers to ensure that the FiO2 is returned to baseline after the 3-hour period has completed.

Monoplace Safety Technical Bulletins:

Technical Memo:

HYCEP Procedure

This is a two-part educational activity:

1. Part one is a video demonstration designed to be a short and effective means of teaching about the risks associated with VAP and demonstrating a procedure to help reduce or mitigate these risks.

HOBIT Trial “HYCEP” Procedure to Reduce Incidents of VAP (Ventilator Associated Pneumonia)

2. Part two is a skills and competency validation that we strongly recommend be completed by all who will be involved with exchanging the ETT cuff from air to normal saline.

Training and Competency Validation for Performing the “HYCEP” Procedures 

HYCEP Attestation 

Clinical Team Training
Ancillary Team Letters 
  • “Dear Nurse” (Hennepin County Medical Center) – The study team can customize, print and provide this letter to the ICU staff that outlines the patient’s treatment group, important reminders, and other pertinent information.
  • “Dear RT” (Hennepin County Medical Center – The study team can customize, print and provide this letter to the RT staff that outlines the patient’s treatment group, important reminders, and other pertinent information.
Pocket Card

Poster for ED 

Simulation Video Examples 

Rationale for the Potential Efficacy of HBO2 in Severe TBI 

Tips and Lessons Learned (Hennepin County Medical Center) – This highlights HCMC’s lessons learned and helpful tips from their first 2 enrollments.

https://www.mdcalc.com/ – This website has calculators to quickly calculate GCS, Serum Osmolality, MAP, and CPP that are useful for the trial. 

HOBIT Clinical Standardization Guideline Flyer – This can be placed on the monitors during study treatments. Updated 5/9/2024

Electronic Informed Consent SOP (description of the central IRB-approved eConsent process)

All HOBIT sites should plan to use the electronic version of the consent form, with paper consent available as a last resort. The eConsent platform, Redcap, has been approved by the central IRB for eConsent use in HOBIT. A demo of the HOBIT eConsent can be found here.

A unique eConsent form link for your site will be provided to you after your site application has received central IRB approval. 

e-Consent Checklist 

Informed Consent Process Overview Video

Objective: To illustrate how a site (Hennepin County) that is very successful at enrolling subjects approaches the informed consent process for HOBIT. This video will demonstrate how to present the HOBIT study to an LAR who may be medically illiterate and may have acute stress and grief from the patient’s condition.

Withdrawal of Consent – Best Practices 

HOBIT Grant (excluding budget) 

IND Approval Letter

To be utilized and completed during the simulation:

HBO Checklist 

Hyperbaric Safety Pause

The following are to assist with planning the simulation, and are NOT meant to be prescriptive, but used as a guide:

Case 1: Longitudinal Simulation Scenario Template + Case Stimuli

Case 2: Complication Simulation Scenario Template + Complication Stimuli

LRT Identification Tool -Use this form during the debrief to document your site’s equipment, knowledge, or process issue that are identified via running the sim and debriefing it.

Sim Video Checklist: Sites can use this checklist to work through the requirements of the sim, and CCC leadership uses it as a guide when reviewing each sites’ sim video.

These videos should be used for educating/training clinical staff and study team members about the study. They should NOT be used as participant recruitment materials. 

Short Version (more specific to the HOBIT Study):

Long Version (more comprehensive information about TBI and the HOBIT Study):

HOBIT CQIP Presentation

Slides