INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery

Table 1 Participant timeline

*Visit*	1	2	3	4		6	7	8
Time (day)		0	*7 +/-2d* ^a	*14 +/-4d*	0	*5+/-2d pod*	*x pod*	*90+/-14 pod*
Patient schedule	*Screening visit*	*Baseline visit*	*Compliance visit*^a	*Admission to hospital*	*Surgery*	*Day 5 after surgery*	*End of hospitalisation*	*End of study visit*
Hospital status	Outpatient				Inpatient			Outpatient clinic
Patient information and informed consent	x
Demographics	x
Medical history	x			x
Medication^b	x			x			x
In-/exclusion criteria	x	x
Administer medical device and training instruction		x
Inspiratory muscle training (IMT)		x	x	x
Power®Breathe device		KHP2^c,KH2	KHP2	KHP2^d		KH2
Compliance check and training performance			x
VAS/NRS/ Vital signs				x		x	x
BMI	x			x
Maximum inspiratory pressure		x		x		x
Load (cmH20), Power (Watt), Breathing Energy (Joule), Volume (l)[measured by Power®Breathe device]		x	x	x		x
Sit-to-stand test		x		x		x
(Serious) Adverse events		x	x	x		x	x	x
Complications							x	x

^aWhen IMT (inspiratory muscle training) > 15 days, patients are offered an additional appointment with physio on demand, scheduled training can be extended up to 6 weeks
^bAntibiotics, immunosuppressants, anticoagulants, insulin, oral antidiabetics
^cHand out Power®Breathe KHP2 device by a physiotherapist to patient
^dReturn of Power®Breathe KHP2 device to the physiotherapist on the ward
pod postoperative day, VAS visual analogue scale, NRS numerical rating scale, BMI body mass index
Control group starts at Visit4: hospital admission. The postoperative procedure is the same for both groups

ISSN: 1745-6215