The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
Primary Purpose
Aspiration Pneumonia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continuous pump feeding
intermittent bolus feeding
Sponsored by
About this trial
This is an interventional prevention trial for Aspiration Pneumonia
Eligibility Criteria
Inclusion Criteria: patients likely to need tube feeding for another 4 weeks Exclusion Criteria: Patients already on pump feeding. Active sepsis: fever, abnormal white cell count CXR shadowing Chronic hypoxia (O2 saturation <92% on room air) Patients who have a history of recurrent self-extubation. Short life expectancy (within weeks)
Sites / Locations
- The Chinese University of Hong Kong
Outcomes
Primary Outcome Measures
pneumonia
Secondary Outcome Measures
mortality
Full Information
NCT ID
NCT00164957
First Posted
September 12, 2005
Last Updated
February 2, 2009
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164957
Brief Title
The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
Official Title
The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
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 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 <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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
222 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
continuous pump feeding
Intervention Type
Other
Intervention Name(s)
intermittent bolus feeding
Primary Outcome Measure Information:
Title
pneumonia
Time Frame
within 4 weeks
Secondary Outcome Measure Information:
Title
mortality
Time Frame
within 4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients likely to need tube feeding for another 4 weeks
Exclusion Criteria:
Patients already on pump feeding.
Active sepsis: fever, abnormal white cell count
CXR shadowing
Chronic hypoxia (O2 saturation <92% on room air)
Patients who have a history of recurrent self-extubation.
Short life expectancy (within weeks)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy CY Kwok, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
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