Surgical Procedure, UnspecifiedPACMANNCT06148701
Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
An observational study of Surgical Procedure, Unspecified and Anesthesia, run by Jeroen Bosch Ziekenhuis at 1 site in Netherlands.
Trial summary
To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified, Anesthesia, Assessment
- How many people
- 1,019 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for all kind of surgical procedures except cardiac surgery and intracranial surgery
Who may be able to join
- >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.
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5200 ME
About this study
Official 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
To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone
Read the 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.
- Conditions
- Surgical Procedure, Unspecified, Anesthesia, Assessment
- Keywords
- Anaesthetists / Health Care Surveys / Preoperative Care / Triage
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between start inclusion and 6 months after start inclusion
Secondary outcomes (3)
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.
Measured: between start inclusion and 6 months after start inclusion
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.
Measured: between start inclusion and 6 months after start inclusion
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.
Measured: between start inclusion and 6 months after start inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Oct 2021
- Primary completion1 Nov 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeroen Bosch Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbe Pieters, Dr.PhD, Principal investigator, Jeroen Bosch Hospital, 's Hertogenbosch The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148701
- Sponsor's protocol ID
- 2021.08.06.01
- Acronym
- PACMAN
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39252617
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06148701
- Acronym / sponsor ID
- PACMAN / 2021.08.06.01
- Conditions
- Surgical Procedure, Unspecified, Anesthesia, Assessment
- Keywords
- Anaesthetists / Health Care Surveys / Preoperative Care / Triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,019 participants (actual)
- Lead sponsor
- Jeroen Bosch ZiekenhuisUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for all kind of surgical procedures except cardiac surgery and intracranial surgery
Key inclusion criteria (1 listed)
- >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.
Key exclusion criteria (1 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Reliability of PACMAN
Time frame: between start inclusion and 6 months after start inclusion
Patients outcome
Time frame: between start inclusion and 6 months after start inclusion
Cost-effectiveness
Time frame: between start inclusion and 6 months after start inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39252617Di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbe Pieters, Dr.PhD principal investigator
Jeroen Bosch Hospital, 's Hertogenbosch The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified and Anesthesia, run by Jeroen Bosch Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the number of in person consultations (time frame: between start inclusion and 6 months after start inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.