Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study.
Study design (if review, criteria of inclusion for studies)
Controlled: Yes.1 Randomised: Yes.2 Open: Yes.3 Single blind: No.4 Double blind: No.5 Parallel group: Yes.6 Cross over: No
Participants
Diagnosis of Cystic Fibrosis. Age 3.0 to 17.9 years. MBW performed in the last 3 days with a relative increase in LCI â¥10% compared to former LCI Two MBW performed in stable condition before inclusion in the last year, both being <10.0 and relative difference less than 15% between each other 6MBW must be performed without sedation and fulfil pre-established quality criteria
Interventions
Multiple Breath Washout (MBW)
Outcome measures
Primary end point(s): Lung Clearance Index (LCI). The primary objective is to show if an increase with â¥10% in LCI compared to former LCI can be reversed with oral antibiotic treatment (and without treatment LCI will remain high or increase). The hypothesis is that the increase in LCI ⥠10% is caused by an increased inflammation from bacterial colonization in the airways.
Keywords: non pharmacological intervention - devices OR physiotherapy;