The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
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|ClinicalTrials.gov Identifier: NCT00164957|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 3, 2009
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.
Randomized controlled trial
Patients expected to remain on tube feeding for 4 or more weeks
1) pneumonia, 2) mortality
|Condition or disease||Intervention/treatment||Phase|
|Aspiration Pneumonia||Device: continuous pump feeding Other: intermittent bolus feeding||Not Applicable|
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.
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.
All the subjects are followed up for four weeks or until outcome is reached (i.e. pneumonia). Mode of tube feeding on discharge will be decided by the attending physicians, patients and family members.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- pneumonia [ Time Frame: within 4 weeks ]
- mortality [ Time Frame: within 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164957
|China, Hong Kong|
|The Chinese University of Hong Kong|
|Hong Kong, Hong Kong, China|
|Principal Investigator:||Timothy CY Kwok, MD||Chinese University of Hong Kong|