Davies 2002.
| Methods | Randomized controlled trial with 2 parallel groups 1 centre Country: Australia |
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| Participants | Medical and surgical intensive care unit Age, years: 55 post‐pyloric; 53 gastric 90% mechanically ventilated APACHE II score: 17.6 post‐pyloric; 18.6 gastric Inclusion criteria 1‐Patient expected to require nutritional and critical care support for at least 3 days Exclusion criteria 1‐Patients unsuitable for passage of a nasoenteral tube (e.g. facial fractures, coagulopathy) 2‐Patient already receiving nutritional support 3‐Patient expected to die within 48 hours 4‐Recent abdominal surgery was not an exclusion criterion Number of participants randomly assigned: 73 Number of participants who received intended treatment: 34 post‐pyloric; 39 gastric Number of participants analysed: 31 post‐pyloric; 35 gastric |
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| Interventions | Post‐pyloric group: 126 cm long, 2.1 mm diameter tube (ENTRAL 204–09, Mallinckrodt, St Louis, MO) was inserted into jejunum by endoscopy over a guidewire. Placement was confirmed and monitored by chest and abdominal radiograph every third day Gastric group: nasogastric or orogastric tube placed into the stomach, with position confirmed by abdominal radiograph Same feeding protocol used in both groups Preventive measure to reduce risk of pneumonia: not mentioned Study ceased when participant discontinued enteral nutritional support, commenced concurrent oral nutrition or was discharged from ICU |
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| Outcomes |
Primary outcome 1‐Tolerance of enteral nutrition, which was measured by gastric residual volume Secondary outcomes 1‐New onset of pneumonia: according to consensus conference definition (clinical criteria, chest X‐ray, changes and microbiological data) 2‐New onset of systemic inflammatory response 3‐New onset of severe sepsis 4‐New onset of septic shock 5‐New onset of acute renal failure 6‐Gastrointestinal bleeding 7‐Diarrhoea 8‐Mortality |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomization was by sealed envelope" Comment: insufficient information to permit judgement of ’high risk’ or ’low risk’ |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomization was by sealed envelope" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded, but outcomes not likely to be influenced Personnel: not mentioned by study authors Comments: personnel probably not blinded, otherwise this would be mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not mentioned by study authors Comments: probably outcome assessments not blinded; otherwise this would be mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data 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 |