ISRCTN ISRCTN91099576
DOI https://doi.org/10.1186/ISRCTN91099576
Sponsor Radboud University Medical Center
Funder Radboud Universitair Medisch Centrum
Submission date
24/02/2026
Registration date
22/03/2026
Last edited
24/02/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Sandra van den Heuvel
Principal investigator, Public

Geert Grooteplein-Zuid 10
Gameren
6525GA
Netherlands

ORCiD logoORCID ID 0000-0002-8292-1692
Phone +31243611111
Email sandra.vandenheuvel@radboudumc.nl
Dr Marieke Voet
Scientific

Geert Grooteplein-Zuid 10
Nijmegen
6525GA
Netherlands

Phone +31243611111
Email Marieke.voet@radboudumc.nl
Dr Jimmy Schenk
Scientific

Meibergdreef 9
Amsterdam
1105AZ
Netherlands

Phone +31205669111
Email j.schenk@amsterdamumc.nl

Study information

Primary study designObservational
Observational study designLongitudinal study
Scientific titleDouble surprise question preoperative anesthesia clinic
Study acronymDSQ-PAC
Study objectives The primary research question is: What is the prognostic accuracy of the DSQ to predict 1-year mortality for patients ≥ ASA 3 undergoing non-cardiac, non-emergency surgery consulted at the PAC?

Secondary research questions are:
1. What is the incidence of inappropriate care (as defined in the Rationale) in surgical patients with a DSQ group 1, and 2 & 3 at the PAC?
2. In how many patients with group 1, 2 and 3 DSQ answers (and patients who died in group 4 DSQ) is an ACP or consultation of a palliative team accessible through the EPD?
3. What are anesthesia providers’ experiences and attitude towards the DSQ at the PAC?
4. A subgroup analysis: What is the prognostic accuracy of the DSQ to predict 1-year mortality for patients ≥ ASA 3 undergoing cardiac, surgery consulted at the PAC?
5. What is the 1-year mortality in the ≥ ASA 3 patients in whom the DSQ was not filled?
Ethics approval(s)

Approved 24/02/2026, METC Oost-Nederland (METC East Netherlands (WMO)) (Philips van Leydenlaan 25, Nijmegen, 6525EX, Netherlands; +3124361 31 54; METCoost-en-CMO@radboudumc.nl), ref: 2025-18457

Health condition(s) or problem(s) studiedPredicting 1-year mortality in surgical ≥ ASA 3 patients at the preanesthesia consultation clinic
InterventionAnesthesia healthcare providers were trained to complete the DSQ during the pre-anesthesia consultation for patients with ASA classification ≥ III undergoing elective non-cardiac surgery (and inclusion of cardiac surgery in Amsterdam). The DSQ was incorporated into the anesthesia questionnaire but was not mandatory, similar to other optional elements of the questionnaire. Consequently, anesthesia providers could finalize the consultation without completing the DSQ. All other steps of the pre-anesthesia consultation were performed as per routine practice.

Patients of whom the DSQ is filled presenting at the anesthesia clinic in Amsterdam and Nijmegen during an approximately six-month period in 2024 will be included in the analysis.
The following demographic and perioperative data will be collected: age (years), weight (kg), ASA classification (III, IV, V), type of surgery, expected and actual duration of surgery, expected and actual blood loss, expected ICU stay, type of anesthesia (general, procedural sedation and analgesia (PSA), neuraxial, locoregional, general/PSA combined with locoregional or neuraxial anesthesia and length of postoperative hospital stay. The consultation of a palliative care team or availability of an ACP in the electronic patient file at the time of the anesthesia consultation or postoperatively will also be recorded.
One year after the PAC, the following data will be collected:
• Survival status of all patients ≥ ASA 3 presented for elective non cardiac surgery.
• For patients in group 1, 2, 3 and patients who died in group 4 the following outcomes will be retrieved from the medical records: provision of chemotherapy or immunotherapy, ≥2 emergency department visits, ≥1 hospital readmission, hospitalization >14 days, ≥1 unplanned intensive care unit admission, and in-hospital death during one-year follow-up or until death, necessity for an new surgery during the same hospital admission, was a palliative consultation or ACP done.
Of the ≥ ASA 3 patients presenting at PAC of whom the DSQ is not filled, we will collect the survival status, age and type of surgery.
Intervention typeOther
Primary outcome measure(s)
  1. One‑year survival probability measured using one‑year follow‑up data collected, during the corresponding six‑month period in 2025, from patients with ASA classification ≥ III undergoing elective non-cardiac surgery recruited from the list of PAC consultations and analysed using a Fisher exact test at one time point
Key secondary outcome measure(s)
Completion date31/12/2026

Eligibility

Participant type(s)
Age groupAll
Lower age limit0 Years
Upper age limit120 Years
SexAll
Target sample size at registration2400
Key inclusion criteria1. ≥ ASA 3
2. elective non-cardiac surgery in Nijmegen and in Amsterdam cardiac surgery patients
3. DSQ is filled during consultation at the PAC
Key exclusion criteria1. ASA < 2
2. No pre-anesthesia consultation
3. Emergency surgery
4. Cardiac surgery in Nijmegen
5. Explicit statement to use of patient data
6. Protected patient file for privacy reasons
Date of first enrolment24/02/2026
Date of final enrolment05/10/2026

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Radboudumc
Geert Grooteplein-Zuid 10
Nijmegen
6525GA
Netherlands
Amsterdamumc
Meibergdreef 9
Amsterdam
1105AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan

Editorial Notes

24/02/2026: Study’s existence confirmed by the METC Oost-Nederland (METC East Netherlands (WMO)).