Please click on the links below for helpful information pertaining to each category:
Chamber Resources (Updated 1-9-23)
Clinical Standardization Guidelines
Education/Training Videos for Clinical and Study Teams
Participant Reimbursement Policy
SIREN-NETT - FWA Requirements for Spokes
FWA Look up: http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc
CLIA Look up: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information.html
Training for Chamber and Subject Log
Multiplace Readiness 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:
No.6 Drip Monitor for Baxter 6201 Flo-Gard IV Pump
Ohmeda Volume Monitors and Battery Use
Ohmeda Battery Charging Cradle
Witt Oxygen Blender and Delta P
Shutting Down the Manifold System
Removing the O2 Sample Flow Indicator
Technical Memo:
No.2 Installation of the 60 Micron Particulate Filter for Magellan
No.3 Removal and Replacement of the Magellan Ventilator
COVID-19 Infection Prevention and Control Considerations for the HOBIT Trial
Use of Camino ICP Monitor in Multiplace Hyperbaric Chamber
Serving the Witt Oxygen Blender (Monoplace)
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
Clinical Team Training
Badge Buddy (Hennepin County Medical Center)
Clinical Team Training PowerPoint (Hennepin County Medical Center)
Investigators Meeting PowerPoint (Modified by: University of Iowa Hospitals and Clinics)
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
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.
High ICP and Low Brain Tissue PO2 Cheat Sheet (Hennepin County Medical Center) - This can be placed on the monitors during study treatments.
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.
DSMB Roster
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 New 8-1-23
HOBIT Grant (excluding budget)
Human Subjects
ER-CIRB Issued Documents:
IRB Approval Letter V7 October 2022
Informed Consent Form - Approved 12 Oct 2020 - This new form contains provisions for collecting blood and CSF samples.
Version 5 – IRB Approval Letter for Protocol 5 Dated April 5th, 2019 and GOSE Video Recording Script
Version 4 – IRB Approval Letter for Protocol 4 and Consent Version 29 Jan 2019
Hyperbaric Oxygen Information for LAR
Sponsor Recruitment Material Approval Notice
Sponsor Subject Material Approval 13 Nov 2019
Certified Letter to LAR (for Lost to Follow Up)
GOSE Schedule of Assessments Handout
Sponsor Subject Material Approval Notice Jan 10, 2020
Ceding Resources:
Participant Reimbursement Policy
HOBIT IRB Approval of Reimbursement Policy
To be utilized and completed during the simulation:
Training for Chamber and Subject Log
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.
Education/Training Videos for Clinical and Study Teams
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
Regulatory Parameters Document
CRFs
WebDCU Cheat Sheet for Study Team Member Changes
ER-CIRB Initial Site Submission Parameters