Mechanical insufflation-exsufflation to promote extubation success in critically ill adults on intensive care: protocol for a randomised controlled feasibility trial

Table 1 Schedule for enrolment, intervention, and follow-up

	Data	Timepoint
	Data	Enrollment	Baseline	Pre-intervention	During intervention	5 min post intervention	Duration of study period	6-month follow-up
Enrolment	Eligibility screening	X
	Consent	X
	Allocation	X
Intervention	Standard care				X
Intervention	MI-E intervention				X
Assessments: baseline demographic outcome	Demographics (age, gender, predicted body weight, history of lung disease, smoking history)		X
	Reason for intubation		X
	Date of hospital and ICU admission		X
	Date of intubation		X
	Ventilator settings		X
	Airway type and size		X
	APACHE II score		X
Assessments: clinical outcomes	Use of HFOT, NIV, tracheostomy						X
	Use of physiotherapy interventions				X
	LUS score			X		X
	Patient pain/discomfort (CPOT; NRS)			X		X
	CVS parameters (HR, SBP, DBP)			X		X
	Ventilator parameters (vent settings, resistance, compliance)			X		X
	Respiratory parameters (RR, SpO₂)			X		X
Assessments: health economics	• Resource use (staffing requirements, suction frequency, consumable use, antibiotic use, physiotherapy on-call use) • QoL (EQ-5D-5L)				X			X
Assessments: safety	Adverse events				X	X	X

Abbreviations: APACHE II Acute Physiology and Chronic Health Evaluation, CPOT Critical Care Pain Observation Tool, DBP Diastolic blood pressure, HFOT High-flow oxygen therapy, hr Heart rate, ICU Intensive care unit, LUS Lung ultrasound, NIV Noninvasive ventilation, NRS Numeric rating scale, SBP Systolic blood pressure, RR Respiratory rate, SpO2 Peripheral oxygen saturations, QoL Quality of life

ISSN: 2055-5784