Montecalvo 1992.
Methods | Randomized controlled trial with 2 parallel groups Multi‐centre Country: Boston, USA |
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Participants | Surgical and medical intensive care unit Age, years: 50.5 post‐pyloric; 44.8 gastric Not clear what percentage of participants were mechanically ventilated APACHE II score: 17.4 post‐pyloric; 16.4 gastric Inclusion criteria 1‐Patient requires tube feeding for at least 3 days 2‐No contraindication to tube feeding or elective endoscopy 3‐No evidence of gastrointestinal bleeding Exclusion criteria Not mentioned Number of participants randomly assigned: 38 Number of participants who received intended treatment: 19 post‐pyloric; 19 gastric Number of participants analysed: 19 post‐pyloric; 19 gastric |
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Interventions | Post‐pyloric group: 60 inch, 12 French feeding tube (Biosearch Medical Products, Somerville) was placed in jejunum endoscopically over guide wire, tube placement was confirmed by X‐ray Gastric group: 43 inch,12 French, radiopaque polyurethane feeding tube was inserted into the stomach Baseline nutritional assessments were similar in both groups, but no standardized protocol was available for management of tube feeding No regular monitoring of tube position Preventive measure to reduce risk of pneumonia: not mentioned Participants were followed for 72 hours after completing tube feeding or for a maximum of 6 weeks of hospitalization |
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Outcomes | 1‐Duration of ICU stay 2‐Duration of mechanical ventilation 3‐Days of antibiotic therapy 4‐Days of fever 5‐Percentage of daily goal caloric intake 6‐Increase in serum pre‐albumin concentration 7‐Days of diarrhoea 8‐Number of participants with vomiting 9‐Number of participants with pneumonia: Pneumonia was diagnosed by presence of infiltrate on CXR plus 3 of the following: A‐Purulent sputum > 25 leucocytes, < 10 epithelial and numerous bacteria B‐Purulent sputum > 25 leucocytes < 10 epithelial and nosocomial pathogens C‐Fever > 38.6 ° C D‐Periphral leucocytosis > 10.000 cells/mm3 10‐Number of times tube was clogged 11‐Number of participants with tube replaced 12‐Gastrointestinal bleeding 13‐Tube insertion complication |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patient randomly assigned according to computer generated randomizations code" |
Allocation concealment (selection bias) | Unclear risk | Nothing 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 not blinded, but outcomes not likely to be influenced Personnel: not mentioned by study authors Comments: Probably personnel were not blinded, otherwise this would be mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "all culture were reviewed ina blinded fashion" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data Uncertain whether analysis was done according to intention‐to‐treat |
Selective reporting (reporting bias) | Low risk | Study protocol is available, and all primary and secondary outcomes have been reported |
Other bias | Unclear risk | Baseline nutritional assessments were similar in both groups, but no standardized protocol was available for management of tube feeding Comment: insufficient information to permit judgement of ’high risk’ or ’low risk’ |