NCT06156033

Brief Summary

This is a prospective, single-center, observational study designed to to quantify complications following non cardiac intermediate and high-risk surgery, and to identify digital biomarkers (collected pre, and post-operatively by a connected device) enabling early early identification of patients with post-operative complications. Patients will be invited to wear a smartdevice during the perioperative period, and will receive questionnaires about their their health status.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

November 23, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
2.3 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

November 23, 2023

Last Update Submit

March 24, 2026

Conditions

Post-Op Complication

Outcome Measures

Primary Outcomes (1)

  • Comprehensive Complication Index

    The primary endpoint was the overall postoperative morbidity following non cardiac intermediate and high-risk surgery as defined by the CCI (Comprehensive Complication Index), which calculates a patient's overall morbidity following surgery based on the Clavien-Dindo classification of complications. The Comprehensive Complication Index (CCI) reflects the severity of this overall burden of complications for the patient on a scale ranging from 0 (no complications) to 100 (death).

    J30 post-op

Eligibility Criteria

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

Patients scheduled for elective non cardiac intermediate or high-risk surgery under general anesthesia

You may qualify if:

  • Patients scheduled for elective non cardiac intermediate or high-risk surgery under general anesthesia
  • years of age or older
  • Capacity to understand french language

You may not qualify if:

  • \- Patient refusal and/or inability to understand and sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Schoettker, Prof

    Centre Hospitalier Universitaire Vaudois

    STUDY DIRECTOR

Central Study Contacts

Bastien Morleo

CONTACT

+41 79 556 59 93bastien.morleo@chuv.ch

Magnus Olofsson

CONTACT

+41 79 556 38 09magnus.olofsson@chuv.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. and Head of department (anesthesiology)

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 5, 2023

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

CH(1)