Wheatley 2018.
| Study characteristics | ||
| Methods |
Phase I: cross‐over RCT, but not randomised and only single intervention in each arm, therefore this part was ineligible for inclusion in the review. Phase II: parallel RCT. |
|
| Participants |
Phase II 12 hospitalised participants (VibraLung® group n = 3; Vest® group n = 9). Mean (SD) age: 23 (6) years. Mean (SD) height: 165 (6) cm. Mean (SD) weight: 60 (10) kg. Mean (SD) BMI: 22 (3) kg/m2. Mean (SD) BSA: 1.7 (0.2) m2. Mean (SD) FEV1 % predicted: 60 (20) %. Mean (SD) FVC % predicted: 76 (18) %. |
|
| Interventions | Phase II: 5 days of in‐hospital therapy for 2 sessions/day with either VibraLung® and the Vest or the Vest® independently. | |
| Outcomes | Phase II: sputum collected for 20 minutes post‐treatment. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Use of a random number generator to assign to 1 of the 3 treatment arms. |
| Allocation concealment (selection bias) | Unclear risk | Not discussed. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not possible to blind participants or clinicians due to the addition of onee or other device. The paper did not alude to blinding of any of the assessors |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Appears to be at least 1 drop out due to admission being shorter than total study time. However paper reports 2 people discharged. Difficulty identifying exactly how many competed the relevant conditions A,B and C and how many did in fact cross over or how many complete data sets there were. |
| Selective reporting (reporting bias) | High risk | Measurement of diffusing capacity of the lungs for Carbon monoxide and nitric oxide, alveolar‐capillarymemberane conductance and pulmonary capillary blood volume and cardiac output was noted as being recorded but this was only described in the results of Phase I. It is not clear if it was measured in Phase II and ommitted from results description. |
| Other bias | Unclear risk | As this was essentially a study to evaluate the safety of the Vibralung, the VEST was used as an additional treatment even through the Vibralung arm of the study. This may have influenced the outcome of the study. |
6MWD: six minute walk distance ACBT: active cycle of breathing ACT: airway clearance technique AD: autogenic drainage BMI: body mass index bpm: bursts per minute CF: cystic fibrosis CFRD: cystic fibrosis‐related diabetes CPT: chest physiotherapy FEF: forced expiratory flow FEV1: forced expiratory volume at one second FVC: forced vital capacity HFCC: high frequency chest compression HFCWO: high force chest wall oscillation IPV: intrapulmonary percussive ventilator ITT: intention to treat IV: intravenous LCI: lung clearance index MEF: mid‐expiratory flow PD: postural drainage PD&C: postural drainage and clapping PD&P: postural drainage and percussion PEF: peak expiratory flow PEP: positive expiratory pressure PO₂: partial pressure of oxygen RCT: randomised controlled trial RFT: respiratory function test RV: residual volume SaO₂: pulse oximetry SD: standard deviation SpO₂: peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood TLC: total lung capacity VC: vital capacity