Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164957
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2005-09-12
Brief Title:
The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
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 60mlhr 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 400mlhr 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 ie pneumonia Mode of tube feeding on discharge will be decided by the attending physicians patients and family members
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 60mlhr 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 400mlhr 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 ie pneumonia Mode of tube feeding on discharge will be decided by the attending physicians patients and family members
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None