Esparza 2001.
Methods | Randomized controlled trial with 2 parallel groups 1 centre Country: New Mexico, USA |
|
Participants | Medical intensive care unit Age, years: 45 post‐pyloric; 50 gastric Mechanically ventilated: 96.3% post‐pyloric; 92.6% gastric APACHE II score: 15.8 post‐pyloric; 17.1 gastric Inclusion criteria Not mentioned Exclusion criteria Not mentioned Number of participants randomly assigned: 54 Number of participants who received intended treatment: 24 post‐pyloric; 27 gastric Number of participants analysed: 27 post‐pyloric; 27 gastric |
|
Interventions | 10 French feeding tube was placed in upper jejunum with the aid of an electromyographic (EMG) electrode 4 cm from the tip (Modified Flexiflo, Ross Product Division, Abbott Laboratories, Columbus, OH, USA), placement was confirmed by a typical gastric or duodenal EMG pattern. Abdominal X‐ray confirmed position of the tube before that start of the feeding. EMG was recorded continuously to monitor correct position Same feeding protocol was used in both groups Participants were studied for up to 8 days, until enteral feeding was no longer required or until isotopic aspiration occurred |
|
Outcomes |
Primary outcome 1‐Difference in aspiration rate between gastric and post‐pyloric fed participants Secondary outcomes 1‐Average daily percentage of goal fed 2‐Mortality |
|
Notes | No standard deviations were reported for average daily percentage of recommended calories received by participant. E‐mail was sent to study author in May, but no reply was received until July 13, 2011 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "feeding tube was placed in the randomly assigned position" Comment: insufficient information to permit judgement of ’high risk’ or ’low risk’ |
Allocation concealment (selection bias) | Unclear risk | Quote: "feeding tube was placed in the randomly assigned position" 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 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: probably not blinded, but outcome is not likely to be influenced |
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 | Unclear risk | Exclusion and Inclusion criteria not mentioned |