Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-09 @ 6:28 PM
Study NCT ID:
NCT06156033
Status:
RECRUITING
Last Update Posted:
2024-08-29
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Smartwatch Monitoring to Predict Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-03', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comprehensive Complication Index', 'timeFrame': 'J30 post-op', 'description': "The primary endpoint was the overall postoperative morbidity following major visceral surgery (such as pancreatic resection or colorectal 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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Op Complication']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center, observational study designed to to quantify complications following major visceral surgery major visceral surgery (such as pancreatic resection or colorectal colorectal surgery), and to identify digital biomarkers (collected pre, and post-operatively by a connected watch) enabling early early identification of patients with post-operative complications. Patients will be invited to wear a watch during the perioperative period, and will receive questionnaires about their their health status.', 'detailedDescription': "Worldwide, the number of surgical procedures is constantly increasing. Major abdominal surgery carries 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 colorectal surgery 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.\n\nIn 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.\n\nAt 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.\n\nWith 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.\n\nThe aim of our study is to analyse the health data collected by a connected watch 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective major visceral surgery (pancreatic resection or colorectal surgery) under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients will be recruited prospectively for a total of 50 patients.\n\nInclusion criteria are :\n\n* Patients scheduled for elective major visceral surgery (pancreatic resection or colorectal surgery) under general anesthesia\n* 18 years of age or older\n\nExclusion criteria will be :\n\n\\- Patient refusal and/or inability to understand and sign informed consent'}, 'identificationModule': {'nctId': 'NCT06156033', 'acronym': 'PreSmart', 'briefTitle': 'Perioperative Smartwatch Monitoring to Predict Complications', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Perioperative Smartwatch Monitoring as a Tool to Predict Post-operative Complications in Patients Undergoing Major Abdominal Surgery. A Single Center Prospective Observational Study.', 'orgStudyIdInfo': {'id': '2023-01186'}}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Henry Benoit', 'role': 'CONTACT', 'email': 'benoit.henry@chuv.ch', 'phone': '+41798828587'}, {'name': 'Magnus Olofsson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Henry Benoit', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Schoettker Patrick, PD-MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Benoit Henry', 'role': 'CONTACT', 'email': 'benoit.henry@chuv.ch', 'phone': '0798828587'}], 'overallOfficials': [{'name': 'Patrick Schoettker, PD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. and Head of department (anesthesiology)', 'investigatorFullName': 'Patrick Schoettker', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}