Methods | RCT. Parallel design. Location: single centre in USA. Duration: total study period of 180 days ‐ 30‐day run in (participant kept a daily log of CPT and aerosol treatment administered) followed by 150 days of treatment. |
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Participants | 20 participants stratified by Schwachmann score and randomised to standard treatment or IPV. 4 dropped out, 16 participants (8 from each group (5 males, 3 females)) completed trial. IPV group mean (range) age: 12 (5 ‐ 24) years. CPT group mean (range) age 10 (5 ‐ 18) years. Participants were well matched to CF severity index, Schwachmann score. Mild to moderate disease severity. | |
Interventions | IPV at least 2x per day compared to standard manual CPT at least 2x daily (included manual percussion for 2 min in each of 10 PD positions). Aerosol treatment was saline or N‐cromolyn and an appropriate volume of albuterol via standard aerosolisation. | |
Outcomes | FVC, FEV₁ and FEF25‐75 measured at baseline, 30 days and at 180 days. Mean days of antibiotic use were documented both for oral and IV antibiotics as needed for hospitalisations. |
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Notes | Aerosolisation of saline or N‐cromolyn and an appropriate volume of albuterol was used via standard aerosolisation in the CPT group. This was the same volume of saline and albuterol as was used in the IPV group. IPV is thought to aid secretion removal by introducing simultaneous application of aerosolisation and intrathoracic percussion using mini‐bursts of gases. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 20 participants stratified by Schwachmann score and randomised to standard treatment or IPV. No further details were reported. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | High risk | No reasons for drop out of 4 participants following randomisation were discussed. |
Selective reporting (reporting bias) | Unclear risk | Not possible to compare study protocol with final paper. |
Other bias | Low risk | Adverse reaction noted and detailed in one participant who experienced minor haemoptysis. |