Multimodal analysis of the effects of dexamethasone on high-altitude cerebral oedema: protocol for a pilot study

Table 2 Schedule of events

Observations and Assessments	Visit 1 – Screening	Randomisation	Visit 2 – Intervention (in hours)																											ET
Observations and Assessments	Visit 1 – Screening	Randomisation	T = 0	1*	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24	25	26	After T = 0
Eligibility confirmation	X
Informed consent	X
Medical history	X
Current medications	X
Demographics	X
MRI safety questionnaire	X		X
Vital signs	X		X		X		X		X		X			X											X		X		X	X
Blood test	X		X								X			X											X				X
Urine Sample^***	X		← Collected throughout the study →
Randomisation		X
Urine pregnancy test (females only)**			X
Venous cannulation			X
Finger-prick test			X								X			X											X				X
MRI scan			X							X				X											X				X
Lake Louise score			X		X		X		X		X			X											X
Administration of IMP or placebo											X
Normoxia at 21% O₂			X																									X	X
Hypoxia at 12% O₂				X	X	X	X	X	X	X	X	X	X	X	X										X	X	X
Hypoxia at 13.5% O₂																X	X	X	X	X	X	X	X	X
Inspired O₂ and CO₂			X	← Every 15 mins →									← Every 30 mins →
AEs and SAEs			←Monitored throughout participation→																											X
End of study																													X
Early termination																														X

AE adverse event, ET early termination, IMP investigational medicinal product, SAE serious adverse event
* Observations will be conducted +/- 30 mins of the stated hour wherever possible. Any deviations will be recorded on the protocol deviation log
**A urine pregnancy test must be carried out on all female participants at visit 2 (intervention visit) prior to conducting any study procedures
*** Urine will be collected in containers provided throughout the study duration, samples collected will be recorded for volume, prepared and stored at -80°C

ISSN: 1745-6215