Aspiration PneumoniaNCT00164957
The Effect of Continuous Versus Enteral Pump Feeding in Aspiration in Tube Fed Patients
A study testing continuous pump feeding and intermittent bolus feeding in people with Aspiration Pneumonia, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- continuous pump feeding and intermittent bolus feeding
- Type of treatment
- Medical device
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- Sep 2002to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients likely to need tube feeding for another 4 weeks
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients
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:
- pneumonia, 2) mortality
Read the 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.
- Conditions
- Aspiration Pneumonia
- Being tested
- continuous pump feeding, intermittent bolus feeding
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous pump feedingDevice
intermittent bolus feedingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumonia
Measured: within 4 weeks
Secondary outcomes (1)
mortality
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Timothy CY Kwok, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164957
- Sponsor's protocol ID
- RCT-pumpfeeding
- Status last verified
- Feb 2009
- First submitted
- 12 Sep 2005
- Last updated
- 3 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous vs Enteral Pump Feeding in Aspiration in Tube Fed Patients
- ClinicalTrials.gov ID
- NCT00164957
- Acronym / sponsor ID
- RCT-pumpfeeding
- Conditions
- Aspiration Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients likely to need tube feeding for another 4 weeks
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous pump feeding | Device | – |
| intermittent bolus feeding | Other | – |
Primary outcome
pneumonia
Time frame: within 4 weeks
1 secondary outcome
mortality
Time frame: within 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy CY Kwok, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous pump feeding and intermittent bolus feeding in people with Aspiration Pneumonia, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pneumonia (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2009.