Primary objective of the study is to determine whether prolonged use of 96 hours leads to growth of microorganisms (type and numbers (CFU/ml)) in enteral tube feeding sets. Secondary objectives are the occurrence of gastrointestinal events/ new…
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of enteral tube feeding sets contaminated with microorganisms
Secondary outcome
The number of contaminated tube feeding sets related to patient cultures
(retrieved from regular patient care) contaminated with the same
microorganism(s).
The number of patients with gastrointestinal events (i.e. diarrhea, vomiting,
nausea, abdominal pain) and new onset of sepsis;
The influence of SDD on the number of gastro-intestinal events and the growth
of microorganisms in enteral tube feeding sets;
The percentage of enteral tube feeding sets that did not endure 96 hours of
use, according to the durability checklist (appendix II);
Number of (serious) adverse events ((S)AE's).
Background summary
The increasing need for sustainability and reducing nursing workload has raised
the question whether the current maximum 24-hour operating time of enteral tube
feeding sets can safely be extended. Therefore, we have previously conducted a
pilot study. This pilot study demonstrated that extended use (1 week) of
enteral tube feeding sets may be feasible and safe. To confirm our preliminary
results, we aim to investigate whether extended usage of enteral tube feeding
sets is also safe when used in daily clinical practice.
Study objective
Primary objective of the study is to determine whether prolonged use of 96
hours leads to growth of microorganisms (type and numbers (CFU/ml)) in enteral
tube feeding sets. Secondary objectives are the occurrence of gastrointestinal
events/ new onset of sepsis, the effect of Selective Digestive Decontamination
(SDD) on the growth of microorganisms and the durability of the enteral tube
feeding sets when used for 96hrs.
Study design
A monocenter exploratory pilot safety trial
Intervention
Extended use of an enteral tube feeding set from 24 hours to 96 hours
Study burden and risks
Risk of this study concerns the potential growth of pathogenic microorganisms
in the enteral tube feeding system. The actual growth of pathogenic
microorganisms cannot be monitored, because findings of the microbiological
cultures take around 2-7 days to arrive, depending on the type and amount of
microorganisms. This suggests that pathogens may be growing with negative
health issues for the patient as a result
koningsplein 1
Enschede 7512KZ
NL
koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
Mentally competent
Age 18 years or older
Treatment with continuous enteral feed is expected to last for at least 96hrs
from inclusion (minimum 20ml/hr)
Gastric/ jejunal tube inserted during current hospital admission
ICU patients: treated with Selective Digestive Decontamination (SDD) which
implies expected mechanical ventilation for more than 48 hours.
Exclusion criteria
Inability to feed enteral due to gastro-intestinal disease
Patients with severe gastro-enteritis (according to doctor*s opinion), chronic
abdominal bowel disease
Patients with immune system disorders
Palliative care
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87418.100.24 |