Day 2001.
| Methods | Randomized controlled trial with 2 parallel groups 1 centre Country: USA |
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| Participants | Neurological intensive care unit Age, years: 53 post‐pyloric; 60 gastric Not stated whether participants were mechanically ventilated APACHE III score: 44.5 post‐pyloric; 51.7 gastric Inclusion criteria 1‐Patient with primary neurological diagnosis 2‐Expected to require enteral feeding for at least 72 hours 3‐Approved for inclusion by their primary physician Exclusion criteria 1‐Patient with documented gastroparesis 2‐Pre‐existing gastrointestinal bleeding 3‐Contraindication to head elevation of at least 30 degrees 4‐Absence of gag reflex Number of participants randomly assigned: 25 Number of participants who received intended treatment: 14 post‐pyloric; 11 gastric Number of participants analysed: 14 post‐pyloric; 11 gastric |
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| Interventions | All participants had a 10 French, 3 gram weighted tip Corflow Ultra NG enteral feeding tube (Corpak Med Syatem) placed in stomach or duodenum. Tube was inserted blindly and position was confirmed by abdominal X‐ray Same feeding protocol was used in both groups Study nutrition period was continued until 10 days after enrolment or participant death |
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| Outcomes |
Primary outcome 1‐Percentage of recommended calories and protein received by participant Secondary outcomes 1‐Physiological effect of feeding 2‐Reasons for delay in feeding 3‐Volume of feeding residual 4‐Number of feeding tubes replaced 5‐Cost of feeding 6‐Numbers and types of complications 7‐Aspiration pneumonia: no definition provided |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Group assignment was performed using a software‐generated randomization schedule" |
| Allocation concealment (selection bias) | Low risk | Quote: "the number generated were placed into sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded, but outcome 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 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 source of bias |