Struik 2011.
| Methods | Single‐centre, open‐label trial with 2 parallel groups | |
| Participants | 16 adults with chest wall deformities and daytime PaCO2 > 45 mm Hg, and one of the following symptoms of nocturnal hypoventilation: daytime sleepiness, fatigue, morning headaches and/or dyspnea, or weight loss. All the participants were NIV‐naïve | |
| Interventions | Control treatment: volume‐targeted NIV during the night‐time Experimental treatment: pressure‐targeted NIV during the night‐time In both arms NIV was titrated to decrease PaCO2 to 45 mmHg, maintain SaO2 above 90%, and improve symptoms while maintaining patient comfort |
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| Outcomes | The number of days needed to successfully establish the patient on NIV, defined as adequate patient adjustment to NIV and effective ventilation (PaCO2 < 45 mm Hg). NIV adjustment was considered adequate when the patient could sleep with the NIV for at least 6 hours per night | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The method for generating the sequence of randomisation was not available |
| Allocation concealment (selection bias) | Low risk | Sealed envelope |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither the participants nor the personnel were blinded to the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome assessors were not blinded to the intervention |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 2 participants did not tolerate volume NIV and switched to pressure NIV after 2 days. 3 participants dropped out: 2 died (1 from cancer, the other from pneumothorax), and 1 did not want to return for measurements in hospital at 3 months |
| Selective reporting (reporting bias) | Unclear risk | No information available |