DETECT Study: Duodenoscopes and linear echo-endoscopes: efficacy of ATP tests compared to visual inspection

Duodenoscopes and linear echo-endoscopes: efficacy of ATP tests compared to visual inspection

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29045

Enrollment

870

Registered

2017-07-11

Start date

2017-07-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contamination microorganisms Disinfection Reprocessing complex flexible endoscopes duodenoscopes linear echoendoscopes ERCP EUS

Interventions

To assess the primary study objective, baseline contamination rates will be determined during the control period and the effect of usage of ATP tests on the contamination rate will be evaluated in the

Eligibility

Inclusion criteria

Inclusion criteria: A potential subject who meets the following criteria is eligible for participation in this study: - ERCP duodenoscopes and linear echo-endoscopes that are: o Reprocessed, including up to 2 ATP tests during the intervention period. o Cultured o Inclusion of duodenoscopes and linear echo-endoscopes is regardless of:  Manufacturer  Type  Age in years  Usage (in number of previous procedures)  Repair history  Ownership: • Endoscopes owned by centers • Endoscopes that are temporarily borrowed from manufacturers  Type of procedure: both diagnostic and therapeutic procedures  ATP testing in the control period

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Flexible endoscope that is any other type than a duodenoscope or linear echo-endoscope. - Duodenoscopes and linear echo-endoscopes that were not reprocessed - Duodenoscopes and linear echo-endoscopes that were not ATP tested during the intervention period

Design outcomes

Primary

Measure	Time frame
To assess if usage of ATP tests in complex endoscopes, i.e. duodenoscopes and linear echo-endoscopes, after manual cleaning combined with re-cleaning protocols, lowers the number of clinically relevant positive cultures.	—

Secondary

Measure	Time frame
2) To assess the relation between the level of organic residue on DLE after manual cleaning, expressed as the amount of ATP in RLU, and the microbiological load on DLE after HLD, expressed as the number of colony forming units. 3) To assess if the use of ATP tests after manual cleaning combined with re-cleaning protocols, facilitates a learning curve in the manual cleaning of duodenoscopes and linear echo-endoscopes, represented by a lower level of organic residue after manual cleaning. 4) To assess which variables affect the costs of using ATP tests after manual cleaning of duodenoscopes and linear echo-endoscopes and the costs of microbial surveillance.	—

Measure

Time frame

2) To assess the relation between the level of organic residue on DLE after manual cleaning, expressed as the amount of ATP in RLU, and the microbiological load on DLE after HLD, expressed as the number of colony forming units. 3) To assess if the use of ATP tests after manual cleaning combined with re-cleaning protocols, facilitates a learning curve in the manual cleaning of duodenoscopes and linear echo-endoscopes, represented by a lower level of organic residue after manual cleaning. 4) To assess which variables affect the costs of using ATP tests after manual cleaning of duodenoscopes and linear echo-endoscopes and the costs of microbial surveillance.

—

Contacts

Public ContactMargreet C. Vos

Erasmus Medisch Centrum Rotterdam - Department of Medical Microbiology & Infectious diseases

m.vos@erasmusmc.nl0107033510

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)