Here are some frequently asked questions:

1. What should I do if my patient is declared dead in the field?

ANSWER: Remove the ITD. Notify the appropriate study coordinators as directed by your agency’s local trial procedures.

2. Does bystander CPR count as the initial CPR period?

ANSWER: No. Bystander CPR does not count. You must still do CPR per the assigned randomization method--Analyze Early or Analyze Late.

3. What if we arrive at a scene and the patient has been analyzed by another defibrillator (e.g., PAD)?

ANSWER: Continue with standard care. This includes analysis by non-ROC responders, layperson AED, etc. The patient may still be enrolled in the ITD part of the study.

4. What if I open an ITD package, but the patient is excluded from the trial?

ANSWER: For purposes of the trial, breaking the seal on the plastic bag means the ITD was used. Do not break the seal on the ITD’s plastic packaging until you have confirmed entry criteria. Tell incoming responders that an ITD is in use when they arrive at the scene to prevent accidental opening of a second bag. If you break the seal on a bag and the ITD is not used, that patient is considered enrolled in the study and you will need to complete all study paperwork.

5. Can I use an ITD on a patient with a tracheostomy? Can I use an ITD with mechanical compression?

ANSWER: No and No.

6. What if my patient develops a pulse?

ANSWER: Immediately remove the ITD from the ventilation device. Resume use of the device if the patient re-arrests.

7. What if the ITD fills with fluid?

ANSWER: Empty the ITD once by blowing out the fluid with your ventilation source. Discontinue use of the device if it fills with fluid again or cannot be cleared. Follow your local protocol if different from the procedure described here.

8. What if an ITD breaks or does not function properly?

ANSWER: Discontinue use by removing it from your ventilation device. Document the problem and return the ITD to your study coordinator.

9. Can I reuse an ITD on another patient?

ANSWER: No. The ITD is for single-patient use only.

10. What if ALS personnel need to administer drugs via the ET tube?

ANSWER: Remove the ITD, inject the medications and then replace the ITD.

11.  What if I open two ITD packages by mistake?

ANSWER:  Do not use the second ITD. Report the opening of both ITDs to the study coordinator.

12. What do I do with the ITD after it has been used?

ANSWER:  If there is any suspected malfunction, return the ITD to your study coordinator. If there are no suspected problems, dispose of it per your study coordinator’s instruction.