Montejo 2002.
| Methods | Randomized controlled trial with 2 parallel groups 14 centres Country: Spain |
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| Participants | Type of intensive care unit not mentioned Age, years: 57 post‐pyloric; 59 gastric Not clear whether participants were mechanically ventilated APACHE II score: post‐pyloric:18; gastric 19 Inclusion criteria 1‐Over 18 years old 2‐Need enteral feeding for longer than 5 days 3‐No contraindication for enteral feed Exclusion criteria 1‐Anatomical disruption of gastrointestinal tract 2‐Previous gastrointestinal surgery 3‐Contraindication to enteral feeding 4‐Contraindication to gastric endoscopy Number of participants randomly assigned: 101 Number of participants who received intended treatment: 50 post‐pyloric; 51 gastric Number of participants analysed: 50 post‐pyloric; 51 gastric |
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| Interventions | Post‐pyloric group: Feeding tube (Stay‐Put, Novartis) was placed in jejunum by endoscopy, fluoroscopy guidance, blind technique or echography. Tube placement was confirmed by abdominal X‐ray Gastric group: Standard nasogastric tube was inserted on admission No regular monitoring of tube position Same feeding protocol was used in both groups Preventive measure to reduce risk of pneumonia: not mentioned Participants were followed up prospectively until ICU discharge or after 28 days follow‐up |
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| Outcomes | 1‐Gastrointestinal complications: abdominal distension, vomiting, diarrhoea, constipation, high gastric residual 2‐Efficacy of diet administration: expressed as ratio between administered and prescribed volumes 3‐Incidence of nosocomial pneumonia: diagnosis according to criteria described by the Centers for Disease Control and Prevention 4‐ICU length of stay 5‐Mortality |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Random numbers were generated by computer for group assignment" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned by study author Comment: insufficient information to permit judgement of ’high risk’ or ’low risk’ |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were blinded, but outcomes were 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 | High risk | Not mentioned by study authors Comments: probably outcome assessment 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 |