Nadler 2017.
Study characteristics | ||
Methods | Design: RCT Date of study: 2014 (unclear ‐ not explicitly reported) Power calculation: yes (study underpowered, baseline rate of delirium lower than expected) Inclusion criteria: aged 50 years or older, at risk of obstructive sleep apnoea as defined by a STOP‐Bang score ≥ 3, scheduled for elective knee or hip arthroplasty, able to speak English, understand consent forms and give informed consent. Exclusion criteria: patients with severe tracheal or lung disease (e.g. bullous lung disease, pneumothorax, recent tracheal anastomosis) or contra‐indications to nasal‐mask CPAP (e.g. facial fractures/lacerations/burns, recent ENT surgery, basilar skull fracture, tracheostomy); Patients with previously diagnosed obstructive sleep apnoea |
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Participants | Sample size: 135 Country: USA Setting: perioperative hospitalised patients undergoing joint arthroplasty population could be shortened to elective orthopaedic Age: mean age 65.1 (SD = 8.4) in intervention group, mean age 66.3 (SD = 9.4) in control group Sex: male, 22 (32.4%) in intervention group, male 24 (35.8%) in control group Co‐morbidity: imbalance in rates of depression and visual or hearing impairment in intervention group compared to control. Dementia: dementia or significant cognitive impairment, 0 in intervention group, 2 (3%) in control group Frailty: not reported |
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Interventions | Intervention: CPAP before surgery and days 0 1 and 2 postoperative (variable amount of time between enrolment and surgery) Control: usual care |
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Outcomes | Outcomes reported: ‐Incident delirium using DRS‐R‐98 diagnostic assessment tool Outcomes from study not reported: ‐Incident delirium using CAM Frequency of outcomes assessment: once post op day 2 |
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Notes | Funding source: Equipment loaned by Philips Respironics, Amsterdam. No other funding source Supported by the Department of Psychiatry Duke University Medical Centre, Durham, NC, USA Declarations of interest: none stated. Delirium not excluded at enrolment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation performed by consulting a computer‐permuted sequence that guaranteed an equal number of patients in each arm within blocks of 20 |
Allocation concealment (selection bias) | Unclear risk | No information provided around how allocations were concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded due to nature of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators performing assessments were blinded to study group assignment and CPA devices were recovered from the group before assessment took place. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Assessments not performed in 10% of intervention group and 13% of control group and unclear why. |
Selective reporting (reporting bias) | Low risk | Outcomes reported as per NCT protocol |
Other bias | Low risk | No evidence of other bias |