Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial

Table 1 Time schedule of enrollment, interventions, assessments, and visits for participants according to Recommendations for Interventional Trials (SPIRIT)

		Study period
		Enrollment	Allocation	Post-allocation			Close-out
Time point		-t1	T0	T1	T2	T3	T4	T5
Enrollment
Eligibility screen		X
Informed consent		X
Allocation			X
Interventions
Control group					X	X
Experimental group					X	X
Outcomes variables
Background information
Socio-demographic and clinical characteristics		X						X
Primary outcome measures
Intracranial compliance	Relation P2/P1			X	X	X	X	X
	TTP			X	X	X	X	X
	Pulse amplitude
Secondary outcome measures
Respiratory mechanics	Static compliance			X	X	X	X	X
	Dynamic compliance			X	X	X	X	X
	Resistance			X	X	X	X	X
	Expired current volume
Hemodynamic stability	MAP			X	X	X	X	X
	HR			X	X	X	X	X
	SpO₂			X	X	X	X	X

TTP time to peak, MAP mean arterial pressure, HR heart rate, SpO ₂ peripheral oxygen saturation

ISSN: 1745-6215