Clinical Trial: The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients
Brief Summary:
Background:
Tube feeding had been found to be a cause of aspiration pneumonia. Continuous pump feeding at slower rates as compared to bolus feeding may be less associated with aspiration pneumonia.
Methods:
Randomized controlled trial
Subjects:
Patients expected to remain on tube feeding for 4 or more weeks
Outcomes:
1) pneumonia, 2) mortality
Detailed Summary:
Eligible subjects are randomized into 2 groups by random numbers generated by a computer programme: intermittent bolus feeding versus continuous feeding via a delivery pump.
Baseline Assessment:
Clinical details including background medical diagnoses, indications for enteral feeding, functional status and baseline CXR findings are recorded.
Tube Feeding Regime:
The choice of feeding formula and feeding volume will be guided by 2 dietitians collaborating in this study. Giving sets for continuous pump feeding are changed everyday.
Pump feeding is defined at delivery rate <60ml/hr. In order to avoid interfering with rehabilitative activities, pump feeding can be discontinued for no more than eight hours during the day. Bolus feeding is defined as no more than 400ml/hr, 4 to 5 times per day.
All subjects are reviewed to monitor complications arising from enteral feeding. Free pump feeding sets will be provided for an extra 2 weeks for pump feeding group subjects discharged before the end of the trial. All subjects discharged prior to the end of trial will be contacted regularly by a research assistant until completion or outcome is reached.
Outcome Pneumonia is diagnosed in the presence of 2 major clinical signs: increased sputum production and pneumonic changes in the CXR (according to radiologist report), or in the presence of one major sign and 2 of the following minor clinical signs: raised or depressed white cell count, hypoxia at room air (PaO2 <92%) and body temperature greater than 38%. When the criteria for pneumonia are fulfilled, the trial will be terminated.
<Sponsor: Chinese University of Hong Kong
Current Primary Outcome: pneumonia [ Time Frame: within 4 weeks ]
Original Primary Outcome: pneumonia within 4 weeks
Current Secondary Outcome: mortality [ Time Frame: within 4 weeks ]
Original Secondary Outcome: mortality within 4 weeks
Information By: Chinese University of Hong Kong
Dates:
Date Received: September 12, 2005
Date Started: September 2002
Date Completion:
Last Updated: February 2, 2009
Last Verified: February 2009
