Acosta‐Escribano 2010.
| Methods | Randomized controlled trial with 2 parallel groups Single centre Country: Spain |
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| Participants | Severe traumatic brain injury patient Mechanically ventilated Mean age: 38 years Male: 86% Median APACHE II score: 17 Inclusion criteria 1‐Age between 18 and 80 years 2‐Glasgow coma scale score < 9 3‐Apache II score between 15 and 30 4‐Sequential organ failure assessment (SOFA) index < 6 (excluding the neurological variable) 5‐Mechanical ventilation required on admission 6‐Artificial nutrition required for at least 5 days Exclusion criteria 1‐Chronic renal failure (plasma creatinine > 2 mg/dL) 2‐Hepatic failure (bilirubin > 3 mg/dL) 3‐Contraindication for enteral nutrition: intestinal inflammatory disease, past history of gastric resection, abdominal surgery within 2 months before inclusion, facial trauma 4‐Treatment with steroid or immunosuppressive drugs 5‐Traumatic spinal cord injury 6‐Pregnancy 7‐Body mass index (BMI) > 35 kg/m2 8‐Severe malnutrition with BMI < 18 kg/m2 9‐Life expectancy less than 5 days 10‐Encephalic death on admission 11‐Refusal to participate 12‐Participation in another clinical study Number of participants randomly assigned: 104 Number of participants who received intended treatment (50 post‐pyloric; 54 gastric) Number of participants analysed (50 post‐pyloric; 54 gastric) |
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| Interventions | Post‐pyloric group: double‐lumen tube (Compat Stay‐Put 9/18) was placed in the jejunum through spontaneous placement or in the radiological suite Position was confirmed by plain abdominal film. No regular monitoring for position of the tube Same feeding protocol was used in both groups Preventive measures were used to reduce risk of pneumonia: head elevation Duration of follow‐up was not mentioned |
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| Outcomes |
Primary outcome 1‐Incidence of nosocomial pneumonia (score > 6 using Clinical Pulmonary Infection Score criteria) Secondary outcomes 1‐Enteral feeding, gastrointestinal complications: abdominal distension, increased gastric residual volume, diarrhoea, aspiration 2‐Achievement of nutritional goal measured in mean efficacious volume (mean volume of diet administered daily) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patient[s] were randomized in 1:1 ratio to one of two treatment group[s]" Method of randomization was not mentioned Information was insufficient to permit judgement of ’high risk’ or ’low risk’ |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned by study authors Information was insufficient to permit judgement of ’high risk’ or ’low risk’ |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open‐label trial" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "open‐label trial" |
| 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 |