Neumann 2002.
Methods | Randomized controlled trial with 2 parallel groups 1 centre Country: California, USA |
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Participants | Medical intensive care unit Age, years: (59.6 Post‐pyloric; 58.1Gastric) Not clear if patient were mechanically ventilated or not Inclusion Criteria Candidate for enteral feeding Exclusion criteria 1‐Gastrointestinal obstruction 2‐Ileus 3‐Pancreatitis 4‐Documented gastroparesis 5‐Inability to obtain informed consent Number of participants who were randomized: 60 Number of participants who received intended treatment: (30 Post‐pyloric; 30 Gatric) Number of participants who were analysed: (30 Post‐pyloric; 30 Gastric) |
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Interventions | Standard 12‐French feeding tube (Dobhoff, Biosearch Medical Products, Somerville, NJ) was placed gastric or post‐pyloric by nursing staff Target position in post‐pyloric group was not clear. Placement was confirmed by X‐ray No regular monitoring of feeding tube position Same feeding protocol was used in both groups Participants were followed‐up for duration of enteral feeding, until leaving ICU or for a maximum of 14 days |
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Outcomes | 1‐Time of initial tube insertion 2‐Onset of feeding 3‐Achievement of goal rate:calculated as mL/h 4‐Adverse outcomes: aspiration, vomiting |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomized using a computer generated, individual number" |
Allocation concealment (selection bias) | Low risk | Quote: "sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded, but outcome is not likely to be influenced Personnel: not mentioned by study authors Comments: probably personnel not blinded, otherwise this would be mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not mentioned by study authors Comments: outcome not likely to be influenced, as incidence of pneumonia was not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing date Intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | Study protocol is available, and all primary and secondary outcomes have been reported |
Other bias | Low risk | Study appears to be free of other sources of bias |