The ACUTE (Ambulance CPAP: Use, Treatment effect and economics) feasibility study: a pilot randomised controlled trial of prehospital CPAP for acute respiratory failure

Table 2 Summary of data collection and trial documentation

What	Where	Who	How		When
				Baseline	Hospital admission	30 days
Consent form
•Verbal consent	Scene of incident	Paramedics	Verbal	X
•Written informed consent	Hospital	Research paramedic	Paper		X
Case report form A
•Patient demographics	Scene of incident/emergency department	Paramedics	Paper	X
•Patient characteristics			Telephone	X
•Prehospital treatments •Adverse events				X X
Case report form B
•Patient demographics	Hospital	Research paramedic	Paper		X
•Baseline quality of life					X
•Inpatient treatments						X
•30-day mortality						X
•Intubation						X
•Critical care admission						X
•Length of stay •Adverse events					X	X
Patient questionnaire
•Quality of life	Home	Patient	Paper			X
•Resource use		Research paramedic	Telephone			X
•Adverse events						X
Paramedic questionnaire
•Acceptability of CPAP	Home/work	Paramedics	Electronic	X
HRA safety report form
•Unexpected related serious adverse events	CTRU	Chief investigator	Electronic	X	X	X
SAE form
•Other serious adverse events	CTRU	Chief investigator	Paper	X	X	X

CTRU clinical trials and research unit, SAE serious adverse event, CPAP continuous positive airways pressure

ISSN: 2055-5784