• SAMPLES

Should we only take samples whilst patients are on PICU

A: Yes, only while a patient is on your PICU. If they are transferred to another ward, we ask you to take samples before this.

 

If an admission sample is missed as it is not part of normal care (e.g. patient is transferred from within the hospital), should we still approach to include the patient?

A: Admission samples should be taken within the timeframe set out locally, and the routine care involved with this. If this time has passed, then it would be great to approach the for consent for the additional samples instead.

 

During an ecology week, do swabs have to happen on a Friday?

A: If you have admissions Thursday onwards, we accept that a second swab may not be possible as we don’t want to add to the workload of the labs over the weekend unless it is deemed feasible by them. 

 

If patient has admission samples taken as routine care and then later becomes eligible it is ok to use these initial samples and just consent for additional? 

A: Yes

 

How does a tracheal aspirate sample get recorded for a tracheostomy patient enrolled during an Ecology week?

A: Please include under ETT section

 

When should we get samples when the patient is on the SDD intervention?

A: Please endeavour to take samples prior to SDD treatment starting

 

• CONSENT

 

Do we need to get consent if additional samples are not possible?

A: Yes, please continue to get consent, using the appropriate version of the Consent Form, for other aspects of the trial (e.g. monitoring of data and the qualitative aspects).

 

If we can’t get consent, should we still input the patient on MACRO?

A: If consent is refused/unable to approach, please continue to collect the anonymous data on the CRFs. You would just not collect information for additional samples or identifiable contact information.

 

How can we give you details for both parents for the qualitative aspect of the trial?

A: Please use 1 consent form to add the necessary contact details.

What date should be use for date of consent on EDGE? 
A: The screening date should be entered as consented date on EDGE. The date of recruitment/randomised should be the date the patient was enrolled and given a study number.

 

 

• ENROLMENT

 

Can a patient be re-enrolled if they get re-admitted to the PICU?

A: Patients cannot be re-enrolled if readmitted

Can a patient be re-screened and enrolled if their circumstances have changed, and they now meet eligibility criteria? 
A: Yes, but only if they were not enrolled beforehand.  

• SDD INTERVENTION

 

When does SDD start and for how long? 
A: SDD treatment should be started within 6 hours of the patient being identified as eligible and continue for a maximum of 30 days (treatment period). Treatment will continue until the patient is extubated / no longer mechanically ventilated. Please note, if it has been more than 6 hours since the patient has been identified as eligible, continue to start SDD treatment.

What happens with patients re-intubated? 
A: Patients subsequently re-intubated following successful extubation during the treatment period (either in this PICU admission or readmission to PICU from another ward in your hospital) will restart the intervention. If the patient was discharged from hospital to their usual care and then readmitted, they should not be re-enrolled.

 

Any SDD intervention treatment recommenced should be recorded on the SDD administration CRF page.

 

How should we treat patients with a trans-anastomotic tube?

A: Patients with a trans-anastomotic tube should only receive SDD oral paste and should NOT be given SDD suspension. The reason for this can be recorded on the SDD deviation page

 

 

What happens to a patient who is already taking any active ingredients of SDD?

A: If a patient is already receiving an active ingredient of the SDD prior to treatment starting, the patient is still eligible to be enrolled, and it is advised:

• If the dose of a single active ingredient is similar or less than that of the SDD treatment, SDD can be used instead of the single constituent.

OR

• If the medical team prefer to continue single agent therapy, SDD should commence following completion of the single agent. The deviation of not receiving SDD until this time should be recording on MACRO.

 

 

• ADVERSE EVENTS

Do Adverse Events need to be recorded if a patient is readmitted?

Adverse events should continue to be recorded for patient readmitted to PICU from another inpatient area. These should be recorded until 30 days from being identified as eligible