- Mar 2023
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www-nejm-org.manchester.idm.oclc.org www-nejm-org.manchester.idm.oclc.org
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In conclusion, this trial showed that patientswith ARDS and severe hypoxemia (as confirmedby a Pao2:Fio2 ratio of <150 mm Hg, with anFio2 of ≥0.6 and a PEEP of ≥5 cm of water) canbenefit from prone treatment when it is usedearly and in relatively long sessions
Prone positioning may be beneficial in a small group of patients
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ified according to ICU. Patients were randomly
Computer randomisation removed human bias, stratification should allow for equal numbers of participants at allocated to each group at each site
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prospective, multicenter,randomized, controlled trial
Prospective - watching for outcomes Multicenter - participants included in the study are from more that one site randomised - refers to the assignment of participants to a particular treatment group controlled - a group does not receive the independent variable being studied
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interval
The probabilyty that 95% of the populaton will fall within this range
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The hazard ratio
HR a measure of how often a particular event occurs in one group to another
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this multicenter, prospective, randomized, controlled trial, we randomly as-signed 466 patients with severe ARDS to undergo prone-positioning sessions of atleast 16 hours or to be left in the supine position.
RCT
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4±4 per patien
What?
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the
stratification doesn't seem to be great and the supine group appear to be sicker.
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229 in the supine groupand 237
some difference in number, could indicate issues with randomisation
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466
456 patients were required according to the power calculation
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The
reduce bias
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Cox proportional-hazards re-gression,
investigating the association between the survival time of patients and one or more predictor variables.
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An absolute dif-ference in mortality of 25 percentage points ormore between groups at the time of the interimanalysis was the only criterion for early trial ter-mination. There was no stopping rule for futility
this was all decided in the study protocol prior to the reseach commencing
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e study would have 90% powerto detect an absolute reduction of 15 percentagepoints (to 45%) with prone positioning,
the probabilty of finding a 15% difference between the 2 means
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redicted bodyweight,
only predicted body weight, not actual. Obesity and low body weight are both likely to impact on patient outcomes.
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Details regarding themanagement of sedation and the use of neuro-muscular blocking agents
this is always open to subjectivity
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ife-threatening hypoxemia
could skew the results
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linician’s discretion
i wonder if there was variability here
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4 hours after the patientwas returned to the supine position.
quite a short period of time, doesn't show whether proing has long-term effects on oxygenation
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articipating centers were given guidelines(see the Supplementary Appendix) to ensure stan-dardization of prone placement. Standard ICUbeds were used for all patients. Patients assignedto the supine group remained in a semirecumbent
Efforts to standardise care other than intervention
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atients assigned to the prone group had to beturned to the prone position within the first hourafter randomization
Seems very quick and could have led to safety incidences although none recorded. Did this mean that some patients were excluded because they were not proned in time?
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The trial was overseen by a steering commit-tee that met monthly
good practice?
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Data collectors were aware of the study-group as-signments, but outcomes assessors were not
some blinding occured
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Written informed consent was obtained after thepatients’ next of kin read the informational leaf-let.
Proxy consent can cause issues. it isn't clear who provided the NoK with the leaflet and whether they had to time to think or were pressured to provide consent immediately
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protocol
study protocol developed before the study commenced, should limit deviation from the precribed care etc.
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26 ICUs in Franceand 1 in Spain,
Can the care recieved here be generalised to the UK?
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less than 36 hours
?they wanted to look at early proning in patients with severe ARDS
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However, meta-analy-ses2,11 have suggested that survival is significantlyimproved with prone positioning as comparedwith supine positioning among patients with se-verely hypoxemic ARDS at the time of random-ization.
?effective in a very specific set of patients
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2013
2013 - pre-Covid
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CT00527813.
a really good abstract that provides a clear and concise overview of the paper
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xcept for the incidence of cardiac arrests,which was higher in the supine group
Interesting
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inclusion
Clear outcome
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0
Provide a clear definition of severe ARDS
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