Follow-up, Data Collection & Safety
Follow-up
Participants should be followed-up to day 30 from randomisation or hospital discharge, whichever comes later.
Follow-up is done by completing an online Case Report Form. If you have been assigned the role of completing these important forms, please ensure you have completed the training on the web page and confirm that you have done this.
All case report forms must be completed online with the exception SAE forms (please see below). These follow-up forms are essential for the trial so thank you for completing them carefully and for all your help with the trial.
|
Visit |
1 |
3 |
4 |
5 |
|
Visit Window (No. Weeks ± No. Days) |
Day 0 Baseline |
Regular in-hospital reviews (at least weekly) |
Day 30 (+/- 2 days)† |
Hospital discharge |
|
Baseline data collection |
X |
|
|
|
|
Randomisation |
X |
|
|
|
|
Intervention |
X |
X |
|
|
|
Adverse events |
|
X |
X |
X |
|
Survival status |
|
X |
X |
X |
|
Outcome assessment |
|
|
X |
X |
Assessing and Reporting AEs, SAEs and Related SAEs
Adverse Events
The protocol states that only AEs clearly related to the use of CPAP or HFNO or expected will be recorded.
Expected adverse events are;
- Interface intolerance due to excessive air leaks
- Pain
- Cutaneous pressure sore or pressure area
- Claustrophobia
- Oro-nasal dryness
- Hypercapnia
- Haemodynamic instability
- Vomiting
- Aspiration of gastric contents
Assessing and Reporting AEs, SAEs and Related SAEs
These events will be included as part of the safety analysis for the trial and do not need to be reported separately to the Trial Coordinating Centre. The local PI will be responsible for confirming the relatedness of any AE to the trial intervention. If an AE occurs, the clinician responsible for the patient should decide whether it is safe to continue CPAP, with or without modification, or whether CPAP should be discontinued.
Serious adverse events
All serious adverse events occurring from the time of randomisation until 30 days post cessation of the trial intervention must be recorded on the Serious Adverse Event reporting form in the participant’s CRF.
The completed SAE forms (initial and follow-up) should be emailed to wctuqa@warwick.ac.uk and RECOVERY-RS@warwick.ac.uk within 24 hours of the research staff becoming aware of it or as soon as is practically possible. Please ensure you follow the NHS encryption guidelines.
All participants experiencing SAEs will be followed-up until the event has been resolved or a final outcome has been reached as per protocol until the end of the trial.
SAEs Exempt from reporting
Events that are common in this population and those that are collected as outcomes of the trial should not be reported as SAEs.
Common SAEs, not for reporting, include:
- Death
- Organ failure
- Pneumonia
- Intubation
- Tracheostomy