Campbell 2016.
Methods |
Design: prospective, RCT Blinding: research associates blinded, participants and personnel unblinded, allocation concealed Dates: April 2006 to April 2010 |
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Participants |
n = 986 Included: adults (aged > 16 years) requiring PSA Excluded: critically ill people or people unable to give consent Location: emergency department, tertiary care university hospital, Canada |
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Interventions |
Control (n = 501) Standard monitoring (cardiac monitoring, blood pressure monitoring, pulse oximetry) Intervention (n = 485) Standard monitoring (as above) and end‐tidal capnography (measured every 5 seconds or absence of waveform at any time) |
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Outcomes |
Primary Oxygen desaturation (< 90% SpO2 for > 30 seconds) Airway interventions (airway repositioning manoeuvre, positive pressure ventilation, oral/nasal airway placement, endotracheal intubation)* Secondary Hypotension (SBP < 100 mmHg or < 85 mmHg if baseline < 100 mmHg) Sedation time (time from first dose of drug administration to commencement of procedure Recovery time (time from end of procedure to cessation of monitoring) Vomiting |
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Funding sources | Research grant from government organization (Capital Health Research Fund, Halifax, Nova Scotia, Canada) | |
Declarations of interest | No authors declared any actual or potential conflicts of interest. | |
Notes | * Published data for airway interventions was continuous. Dichotomous data obtained by contacting authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned to each group by research associates (blinded) using computer‐generated randomization. |
Allocation concealment (selection bias) | Low risk | Allocation concealed using opaque white envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No data excluded, all data included in analysis. |
Selective reporting (reporting bias) | Unclear risk | All participants accounted for. Study was not enrolled in a trial registry and thus modifications to the study methods could not be assessed. |
Other bias | Low risk | Funding: supported by an independent government grant. |