NCT06410183

Brief Summary

The goal of this study is to investigate the inter-rater variability of mortality risk calculations for high-risk non-cardiac surgical patients. For this purpose patient information from health care files were used. Five anesthesiologists calculated the mortality risks with three calculators for 34 high-risk non-cardiac surgical patients. The patients were discussed in a preoperative multidisciplinary discussion in a large teaching hospital in The Netherlands.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Typical duration 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

February 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

April 25, 2024

Last Update Submit

June 10, 2024

Conditions

Reliability

Keywords

preoperativehigh-risk patient

Outcome Measures

Primary Outcomes (1)

  • inter-rater reliability of three risk calculators: POSPOM, SRC and SORT

    Five anesthesiologists calculated mortality risks retrospectively for 34 patients. The intra-class correlation coefficient (ICC) was calculated per risk calculator

    After calculation of the mortality risks (1 month)

Secondary Outcomes (1)

  • mortality risk calculations or 34 patients

    1 month

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

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

HIgh-risk non-cardiac surgical patients discussed in an MDT meeting.

You may qualify if:

  • Patients discussed in a preoperative multidisciplinary team (MDT) meeting.

You may not qualify if:

  • No complete patient file to calculate the mortality risks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Study Officials

  • Jacqueline E. Vernooij, MD, MA

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 13, 2024

Study Start

February 1, 2019

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 12, 2024

Record last verified: 2024-06

Locations

NL(1)