- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148701
Preoperative Anesthesia Automatic System:a Retrospective Cohort Study (PACMAN)
November 20, 2023 updated by: Jeroen Bosch Ziekenhuis
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
To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
1019
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Brabant
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's-Hertogenbosch, Brabant, Netherlands, 5200 ME
- Jeroen Bosch ziekenhuis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for all kind of surgical procedures except cardiac surgery and intracranial surgery
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of the number of in person consultations
Time Frame: between start inclusion and 6 months after start inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of PACMAN
Time Frame: between start inclusion and 6 months after start inclusion
|
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
|
Patients outcome
Time Frame: between start inclusion and 6 months after start inclusion
|
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
|
Cost-effectiveness
Time Frame: between start inclusion and 6 months after start inclusion
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbe Pieters, Dr.PhD, Jeroen Bosch Hospital, 's Hertogenbosch The Netherlands
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
November 20, 2023
First Submitted That Met QC Criteria
November 20, 2023
First Posted (Actual)
November 28, 2023
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2021.08.06.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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