Post-Op ComplicationPreSmartNCT06156033
Perioperative Smart Device Monitoring to Predict Complications
An observational study of Post-Op Complication, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Op Complication
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 elective non cardiac intermediate or high-risk surgery under general anesthesia
Who may be able to join
- Patients scheduled for elective non cardiac intermediate or high-risk surgery under general anesthesia
- 18 years of age or older
- Capacity to understand french language
Who cannot join
- Patient refusal and/or inability to understand and sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
CHUV
Lausanne, Canton of Vaud, 1011
Henry Benoit, +41798828587, benoit.henry@chuv.ch
Magnus Olofsson, MD
About this study
Official title: Perioperative Smart Device Monitoring as a Tool to Predict Post-operative Complications in Patients Undergoing Non Cardiac Intermediate and High-risk Surgery. A Single-center Prospective Observational Study
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.
Read the detailed description
Worldwide, the number of surgical procedures is constantly increasing. Non cardiace intermediate and high-risk surgeries carry a high risk of complications, both because of the specific nature of the surgery and because of the various pathologies affecting the patient's functional reserves. As the population ages, it is estimated that the number of people requiring complex surgeries will continue to rise. To identify patients at high risk of developing intra- and post-operative complications, several tools have been described that are based on the physical characteristics (e.g. Revised Cardiac Risk Index, functional capacity assessment, or biological characteristics) of individuals. Once a patient is considered to be at risk, their intraoperative course should be adapted and individualised in order to reduce the rate of complications. Such preoperative management is rarely offered, either because of the resources allocated, the time available or incomplete risk stratification.
In recent years, advances in the digitisation of medicine, particularly since the Covid-19 pandemic, have gradually been made available to patients. Technological advances now make it possible to collect accurate, continuous data on vital parameters, which can be analysed and exploited by the medical world, even before the patient is seen in consultation.
At present, health data is collected in a standardised way preoperatively, incorporating routine examinations carried out by general practitioners or specialists in the event of specific problems known or identified at an early stage. On the other hand, the vast majority of measurements are episodic and isolated, carried out in situations that do not necessarily reflect the day-to-day lives of individuals (office-based medicine). There are now technologies that allow digital data to be collected on a daily basis, in the patient's environment (home-based medicine), and on a continuous basis over several days. The collection of digital biomarkers over a long period of time, non-invasively and remotely, enables an assessment to be made that reflects the day-to-day reality of an individual's physiology, in contrast to episodic measurements in an unfamiliar environment.
With the availability of biomedical data collected on a continuous basis, combined with data based on sensors integrated into certain devices (e.g. accelerometers), relevant information on the particular lifestyle of each individual could make it possible to identify points of attention, possibly indicative of specific functional limitations. In this way, it would be possible to generate a digital clone of an individual, and to identify in greater detail the areas of reinforcement specifically required by each individual in the pre-operative phase. In addition, access to this type of data by healthcare professionals would provide an opportunity for better stratification of surgical risks and better preparation for surgery. This will make it possible to practise personalised medicine based on evidence. For high-risk surgical patients, preoperative, intraoperative and postoperative management could be optimised and personalised according to the data collected in the preoperative phase. For example, by proposing a prehabilitation programm. It would also allow better identification of the optimal surgical window.
The aim of our study is to analyse the health data collected by a connected smartdevice from surgical patients in the pre-operative period, and to establish a possible link between these parameters and the occurrence of post-operative complications. We want to study the predictive potential of these variables.
This connected preoperative monitoring could make it possible to identify individuals prone to complications early, non-invasively, in a personalised manner and in their usual environment. The collection of digital biomarkers specific to each patient will open the door to individualised, precision and predictive medicine, making it possible to offer a care pathway tailored to the needs of each patient prior to surgery.
- Conditions
- Post-Op Complication
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: J30 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Apr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker, Centre Hospitalier Universitaire Vaudois
- Investigators
- Patrick Schoettker, Prof, Study director, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156033
- Sponsor's protocol ID
- 2023-01186
- Other IDs
- 2023
- Acronym
- PreSmart
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Smart Device Monitoring as a Tool to Predict Post-operative Complications in Patients Undergoing Non Cardiac Intermediate and High-risk Surgery. A Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06156033
- Acronym / sponsor ID
- PreSmart / 2023-01186
- Conditions
- Post-Op Complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Dec 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.
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.
Detailed description
Worldwide, the number of surgical procedures is constantly increasing. Non cardiace intermediate and high-risk surgeries carry a high risk of complications, both because of the specific nature of the surgery and because of the various pathologies affecting the patient's functional reserves. As the population ages, it is estimated that the number of people requiring complex surgeries will continue to rise. To identify patients at high risk of developing intra- and post-operative complications, several tools have been described that are based on the physical characteristics (e.g. Revised Cardiac Risk Index, functional capacity assessment, or biological characteristics) of individuals. Once a patient is considered to be at risk, their intraoperative course should be adapted and individualised in order to reduce the rate of complications. Such preoperative management is rarely offered, either because of the resources allocated, the time available or incomplete risk stratification.
In recent years, advances in the digitisation of medicine, particularly since the Covid-19 pandemic, have gradually been made available to patients. Technological advances now make it possible to collect accurate, continuous data on vital parameters, which can be analysed and exploited by the medical world, even before the patient is seen in consultation.
At present, health data is collected in a standardised way preoperatively, incorporating routine examinations carried out by general practitioners or specialists in the event of specific problems known or identified at an early stage. On the other hand, the vast majority of measurements are episodic and isolated, carried out in situations that do not necessarily reflect the day-to-day lives of individuals (office-based medicine). There are now technologies that allow digital data to be collected on a daily basis, in the patient's environment (home-based medicine), and on a continuous basis over several days. The collection of digital biomarkers over a long period of time, non-invasively and remotely, enables an assessment to be made that reflects the day-to-day reality of an individual's physiology, in contrast to episodic measurements in an unfamiliar environment.
With the availability of biomedical data collected on a continuous basis, combined with data based on sensors integrated into certain devices (e.g. accelerometers), relevant information on the particular lifestyle of each individual could make it possible to identify points of attention, possibly indicative of specific functional limitations. In this way, it would be possible to generate a digital clone of an individual, and to identify in greater detail the areas of reinforcement specifically required by each individual in the pre-operative phase. In addition, access to this type of data by healthcare professionals would provide an opportunity for better stratification of surgical risks and better preparation for surgery. This will make it possible to practise personalised medicine based on evidence. For high-risk surgical patients, preoperative, intraoperative and postoperative management could be optimised and personalised according to the data collected in the preoperative phase. For example, by proposing a prehabilitation programm. It would also allow better identification of the optimal surgical window.
The aim of our study is to analyse the health data collected by a connected smartdevice from surgical patients in the pre-operative period, and to establish a possible link between these parameters and the occurrence of post-operative complications. We want to study the predictive potential of these variables.
This connected preoperative monitoring could make it possible to identify individuals prone to complications early, non-invasively, in a personalised manner and in their usual environment. The collection of digital biomarkers specific to each patient will open the door to individualised, precision and predictive medicine, making it possible to offer a care pathway tailored to the needs of each patient prior to surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective non cardiac intermediate or high-risk surgery under general anesthesia
Key inclusion criteria (3 listed)
- Patients scheduled for elective non cardiac intermediate or high-risk surgery under general anesthesia
- 18 years of age or older
- Capacity to understand french language
Key exclusion criteria (1 listed)
- Patient refusal and/or inability to understand and sign informed consent
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
Comprehensive Complication Index
Time frame: J30 post-op
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Patrick Schoettker, Prof study director
Centre Hospitalier Universitaire Vaudois
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 Post-Op Complication, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 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: opening soon, as of the sponsor's last update on 27 Mar 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bastien Morleo (+41 79 556 59 93, bastien.morleo@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (time frame: J30 post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.