Anesthesia Clinical Trial
— PACMANOfficial title:
The Preoperative Anesthesia automatiC systeM for triAge and screeNing (PACMAN) as a Model for Recognition of Patients Who May Screened by Phone: a Retrospective Cohort Study
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 |
Verified date | November 2023 |
Source | Jeroen Bosch Ziekenhuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Brabant |
Lead Sponsor | Collaborator |
---|---|
Jeroen Bosch Ziekenhuis |
Netherlands,
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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