Boivin 2001.
| Methods | Randomized controlled trial with 2 parallel groups 1 centre Country: New Mexico, USA |
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| Participants | Medical, surgical and neuroscience intensive care unit 99% mechanically ventilated Age, years: 49 post‐pyloric; 48 gastric APACHE II score: 17 post‐pyloric; 16 gastric Inclusion criteria 1‐Patients 18 years of age or older needing enteral feed as decided by treating team Exclusion criteria 1‐Patients who were already being fed 2‐Pancreatitis 3‐Burns 4‐Severe head injury (Glasgow Coma Score < 6) 5‐Pregnant 6‐Prisoners 7‐Patients with previous gastric surgery 8‐Ongoing gastrointestinal bleeding 9‐Expected need for tube feeding was < 72 hours Number of participants randomly assigned: 80 Number of participants who received intended treatment: 39 post‐pyloric; 39 gastric Number of participants analysed: 39 post‐pyloric; 39 gastric |
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| Interventions | Post‐pyloric group: 10‐Fr weighted feeding tube (Flexiflo, Ross Product Div., Abbott Laboratories) was placed blindly by investigator. Target location was not mentioned, and placement was confirmed and monitored by chest and abdominal radiographs Gastric group: nasogastric or orogastric tube placed into the stomach, position confirmed by abdominal radiograph, patients receiving erythromycin (200 mg) every 8 hours to increase gastric motility Same feeding protocol was used in both groups Partiicpants were studied until they were able to tolerate oral intake or until 96 hours had elapsed |
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| Outcomes |
Primary outcome 1‐Percentage of recommended calories received by participant Secondary outcomes 1‐Time required to achieve full nutritional target 2‐Daily percentage of goal rate 3‐Change in albumin, pre‐albumin 4‐PaO2/FIO2 index (partial pressure of arterial oxygen tension/fraction of inspired oxygen) 5‐Mortality |
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| Notes | No standard deviations were reported for percentage of goal rate achieved; time from enrolment to insertion of feeding tube; and time from enrolment to initiation of feeding. E‐mail was sent to study author, who replied but did not provide further data until November 2013 Duration of mechanical ventilation was not reported; study authors reported ventilator‐free days; therefore this outcome was not included in our analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "random number table in blocks of ten" |
| Allocation concealment (selection bias) | Unclear risk | Information was insufficient to permit judgement of ’high risk’ or ’low risk’ |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded, but outcome was not likely to be influenced Personnel: blinding not mentioned by study authors Comments: personnel probably were 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 | Unclear risk | No missing outcome data Uncertain whether analysis was done by intention‐to‐treat Standard deviation was not available for some outcomes |
| Selective reporting (reporting bias) | Low risk | Study protocol available, and all primary and secondary outcomes reported |
| Other bias | Low risk | Study appears to be free of other sources of bias |