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. 2015 Aug 4;2015(8):CD008875. doi: 10.1002/14651858.CD008875.pub2

Montecalvo 1992.

Methods Randomized controlled trial with 2 parallel groups
Multi‐centre
Country: Boston, USA
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 
 
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
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
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’