Please click on the links below for helpful information pertaining to each category:
Chamber Resources (Updated 3-6-20)
IRB (Updated 1-10-20)
FDA Form 1572 (updated 2/16)
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:
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.
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.
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.
Simulation Video Examples
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.
HOBIT Grant (excluding budget)
ER-CIRB Issued Documents: (Updated 1-10-20)
Master Informed Consent Form – 29 Jan 2019 (US and Canada)
GOSE Schedule of Assessments Handout (NEW 1-10-20)
Sponsor Subject Material Approval Notice Jan 10, 2020 (NEW 1-10-20)
Short Form Collection:
To be utilized and completed during the simulation:
HBO Checklist (Updated 9-3-19)
Chamber and Subject Log v.5 (Updated 11-15-19)
Training for Chamber and Subject Log (New 10-4-19)
The following are to assist with planning the simulation, and are NOT meant to be prescriptive, but used as a guide:
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 (Updated 9-3-19): 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.