NCT06148701

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,019

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 20, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

Anaesthetists / Health Care Surveys / Preoperative Care / Triage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reliability of PACMAN

    between start inclusion and 6 months after start inclusion

  • Patients outcome

    between start inclusion and 6 months after start inclusion

  • Cost-effectiveness

    between start inclusion and 6 months after start inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for all kind of surgical procedures except cardiac surgery and intracranial surgery

You may qualify if:

  • \>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.

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5200 ME, Netherlands

Location

Related Publications (1)

  • Di Biase M, van der Zwaard B, Aarts F, Pieters B. Pre-operative triAge proCedure to streaMline elective surgicAl patieNts (PACMAN) improves efficiency by selecting patients eligible for phone consultation: A retrospective cohort study. Eur J Anaesthesiol. 2024 Nov 1;41(11):813-820. doi: 10.1097/EJA.0000000000002055. Epub 2024 Sep 9.

Study Officials

  • Barbe Pieters, Dr.PhD

    Jeroen Bosch Hospital, 's Hertogenbosch The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

October 1, 2021

Primary Completion

November 1, 2021

Study Completion

June 1, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations