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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Netherlands
    • Brabant
      • 's-Hertogenbosch, Brabant, Netherlands, 5200 ME
        • Jeroen Bosch Ziekenhuis

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jeroen Bosch Ziekenhuis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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