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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06148701
Other study ID # 2021.08.06.01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date June 1, 2022

Study information

Verified date November 2023
Source Jeroen Bosch Ziekenhuis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone


Description:

PACMAN triage system consists of a health questionnaire and an algorithm. Patient were called up by registered nurses and asked to answer the questionnaire. Patients answers were applied to PACMAN algorithm to determine what kind of screening patient should receive: in person or by phone.


Recruitment information / eligibility

Status Completed
Enrollment 1019
Est. completion date June 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 years old, scheduled for elective clinical interventions under procedural sedation and all types of elective medium or low risk surgery with anaesthetic guidance, as defined by the European Society of Anaesthesia (ESA) guidelines. Exclusion Criteria: - <18 years. Patients scheduled for emergency and high-risk surgery were excluded as the policy of our department dictates that these patients must always be seen in person, according to ESA guidelines.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Jeroen Bosch Ziekenhuis 's-Hertogenbosch Brabant

Sponsors (1)

Lead Sponsor Collaborator
Jeroen Bosch Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of the number of in person consultations In 2019 all patients were screened in person. Aim of the study is to evaluate whether implementation of PACMAN leads to a significant reduction of the number of in person consultations between start inclusion and 6 months after start inclusion
Secondary Reliability of PACMAN Reliability of the triage procedure was evaluated by verifying the PACMAN outcome (PhC vs in-PC) against the assigned ASA-PS classification. Patients scheduled for a PhC were considered to be accurately triaged if classified ASA-PS I-II or III with stable comorbidities. Patients scheduled for an in-PC were considered to be accurately triaged if classified ASA-PS III with unstable comorbidities or IV. between start inclusion and 6 months after start inclusion
Secondary Patients outcome To measure the impact of PACMAN on patient outcomes we evaluated the occurrence of perioperative unanticipated adverse events (UAE). An anaesthesia-related UAE was defined as an event causing mortality or morbidity, occurring during the perioperative period or up to seven days after surgery and requiring special medical treatment or prolongation of hospitalisation beyond the expected length of stay. Data concerning perioperative UAE were collected by reviewing the EMR of patients who had undergone surgery. between start inclusion and 6 months after start inclusion
Secondary Cost-effectiveness we examined cost-effectiveness and efficiency by determining the time taken by screening staff for a single PhC or in-PC and the average number of patients screened before and after implementation of PACMAN along with related staff costs. between start inclusion and 6 months after start inclusion
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