The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients

Aspiration Pneumonia Clinical Trial

Official title:

The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164957
• Other study ID #: RCT-pumpfeeding
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: February 2, 2009
• Start date: September 2002
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia, Aspiration

Intervention

Device:
• continuous pump feeding

Other:
• intermittent bolus feeding

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pneumonia		within 4 weeks
Secondary	mortality		within 4 weeks