Conservative Management in Traumatic Pneumothoraces in the Emergency Department (CoMiTED): A Randomised
Controlled Trial
Guide to enrollment
Decide on Eligibility:
Inclusion Criteria:
Patients presenting with traumatic pneumothorax or pneumothoraces
16 years and over, (or believed to be)
Treating clinician believes either a chest drain or conservative management would be a suitable initial
treatment option
Exclusion Criteria:
Treating clinician(s) believe injuries are incompatible with life
Respiratory arrest
Haemothorax (associated with pneumothorax) requiring a chest drain in teh opinion of the treating clinician(s)
Clinical and imaging evidence of tension pneumothorax in either lung
Prisoners (NB: “prisoners” does not include those in police custody; only those detained in prison
establishments)
If the patient is eligible for the study:
Many eligible patients will temporarily lack capacity to fully consent to research.
In such cases they can be considered for enrollment and the research team will gain consent later.
To proceed, select the patients capacity status below:
Actions to take to enroll the patient:
In standard working hours; 9-5
Please contact the ED Research Team when eligible patients arrive in ED:
Send the ED Research Team a message via Epic chat "ED research Team" or phone 217907
Out of hours and weekends:
First select an option: Does the patient have capacity to consent?
For the patient with capacity:
First, gain verbal agreement in principle before proceeding. Explain:
Taking part in research is likely to improve the quality of their care
Risks are carefully controlled - research is safe
Explain the uncertainty that exists; for example, we do not know if their condition is best managed with usual care or the alternative under investigation
If they change their mind they can withdraw their participation at any point
Steps to enroll the patient:
Eligibility: Enrollment requires one trained Dr or Nurse who is on the Delegation Log.
To find if anyone on shift is on the delegation log, check the Sharepoint folder here,
0r find it in sharepoint manually at this location:
'CUH Emergency Department ⤷ Research in the ED ⤷ Training information ALL TRIALS ⤷ Delegation Log Spreadsheet', or click to see if anyone on shift is.
Collect a BLUE patient pack from the rack in the ambulance bay next to the automatic doors
Screening: Complete pages 1, 2, 3 and 4 of the screening Case Report Form (CRF)
Give the Patient Information Sheet to the patient A paper copy is in the pack; and an electronic version can be found here:
QRc link to patient information page and video, if the patient is happy to use their phone.
Consent: Complete the consent form with the patient.
If the patient has capacity but is physically unable to sign, e.g. due to injuries, arrange for a witness to sign the consent - can be any relative or staff member.
The username and password for Sealed Envelope is on the front page of the per patient paperwork packs
Complete page 6 of the Screening CRF
Complete the Baseline questionnaire with the patient (a relative or HCA can do this)
If required by randomisation, insert ICD
Document using SmartPhrase .COMITED in the notes
Send the ED Research Team an EPIC message with the patient details attached.
Place the signed Screening Form; Consent Form and Questionnaire in the Letterbox in ED reception (on the wall behind the receptionists)
For the patient who does not have full capacity:
Eligibility: Two doctors are required to assess eligibility: One must be on the delegation log and the other must not be on the delegation Log
To find if anyone on shift is on the delegation log, check the Sharepoint folder here,
0r find it in sharepoint manually at this location:
'CUH Emergency Department ⤷ Research in the ED ⤷ Training information ALL TRIALS ⤷ Delegation Log Spreadsheet', or click to see if anyone on shift is.
Collect a BLUE patient pack from the rack in the ambulance bay next to the automatic doors.
Screening: Complete pages 1, 2, 3 and 5 of the Screening Case Report Form (CRF) Form. Both doctors need to sign page 5 where prompted.
