Safety Reporting Clarification and updated CRF

Mon, 21 Dec 2020 11:04:22 GMT

We wish to provide clarification regarding the Safety Reporting requirements for the RECOVERY-RS Trial and notify you of the updated Data Collection CRF.

When assessing whether to record Adverse Events (AE’s) on the e-CRF, please only capture events that are CLEARLY RELATED (i.e. are suspected to have been caused by the administration of CPAP or HFNO). The list below are examples of SAEs that can be caused by non-invasive ventilation. This list is not exhaustive so any other event that has a potential causal relationship should still be captured on the e-CRF:

Interface intolerance due to excessive air leaks
Pain
Cutaneous pressure sore or pressure area
Claustrophobia
Oro-nasal dryness
Respiratory acidosis with pH <7.25 prior to intubation
Haemodynamic instability
Vomiting
Aspiration of gastric contents

Examples of other related events are pneumothorax and pneumomediastinum. Please note these events are now listed on the updated Data Collection CRF – v4.0 08 December 2020. Please use and file this version moving forward alongside the updated <u>master documents version log</u> – v9.0 21 Dec 2020.

When assessing Serious Adverse Events, as per protocol section 4.1.4, events that commonly occur in this population and those that are collected as outcomes of the trial should NOT be reported as SAEs.

As a reminder this means the following events are EXEMPT from SAE reporting:

Death
Organ failure
Pneumonia
Intubation
Trachostomy

Events that are related to the patient’s underlying disease or condition should not be reported as this is not a relevant requirement for the trial.

Safety Alert: High-flow oxygen devices, including real-world incident

Sun, 05 Apr 2020 16:00:00 GMT

NHSEI issued an Urgent Patient Safety Notice regarding the “Use of high flow oxygen therapy devices (including wall CPAP, and high flow face mask or nasal oxygen) during the Coronavirus epidemic” on 31 March 2020 (NHSE/I – 2020/001). The alert required immediate action from all hospitals to mitigate the risk posed by the use of multiple high flow devices, and highlighted “If the demand through multiple wall outlets exceeds the maximum capacity of the VIE delivery system, there is a risk of a rapid pressure drop in oxygen supply pipes.

Clinical Trials Unit » News (tag [Safety])

Safety Reporting Clarification and updated CRF

Safety Alert: High-flow oxygen devices, including real-world incident