Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-15 @ 6:05 AM
Study NCT ID:
NCT04920604
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elevated American Society of Anesthesiologists (ASA) score in each group', 'timeFrame': 'anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Yes/no for if score=3-4'}, {'measure': 'Elevated American Society of Anesthesiologists (ASA) score in each group', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': 'Yes/no for if score=3-4'}, {'measure': 'Difficulty in accessing airways each group', 'timeFrame': 'anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Yes/no for mouth opening ≥35 mm'}, {'measure': 'Difficulty in accessing airways each group', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': 'Yes/no for mouth opening ≥35 mm'}, {'measure': 'Medication conciliation performed during the anesthesia consultation each group', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': 'Yes/no: adaptations of selected therapies: anticoagulants, anti-aggregants, anti-hypertension, antidiabetics'}, {'measure': 'Medication conciliation performed during the anesthesia consultation each group', 'timeFrame': 'anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Yes/no: adaptations of selected therapies: anticoagulants, anti-aggregants, anti-hypertension, antidiabetics'}, {'measure': 'Difference between groups in composite score of above outcomes (elevated ASA score, difficulty accessing airways and medication conciliation)', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': 'Difference in number of yes/no answers at anesthesia consultation compared to pre- anesthetic visit'}, {'measure': 'Difference between groups in composite score of above outcomes (elevated ASA score, difficulty accessing airways and medication conciliation)', 'timeFrame': 'anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Difference in number of yes/no answers at anesthesia consultation compared to pre- anesthetic visit'}], 'secondaryOutcomes': [{'measure': 'Number of canceled surgeries in each group', 'timeFrame': 'Day 2 after pre-anesthetic visit', 'description': 'Yes/no surgery not performed on the scheduled day and / or postponed \\> 2 days'}, {'measure': 'Reason for cancellation of surgery', 'timeFrame': 'Day 2 after pre-anesthetic visit', 'description': 'Description noted in electronic clinical report form'}, {'measure': 'Number of delayed surgeries in each group', 'timeFrame': 'Day 2 after pre-anesthetic visit', 'description': 'Yes/no surgery not performed on the scheduled day and / or postponed ≤ 2 days'}, {'measure': 'Reason for delayed surgery', 'timeFrame': 'Day 2 after pre-anesthetic visit', 'description': 'Description noted in electronic clinical report form'}, {'measure': 'Complication rate in perioperative and immediate postoperative period', 'timeFrame': '2 days post-operatively', 'description': '% patients with a complication'}, {'measure': 'Rate of anesthesia consultation rescheduling in each group', 'timeFrame': '2 days after pre-anesthetic visit', 'description': 'Number of consultations rescheduled'}, {'measure': 'Reason for rescheduling', 'timeFrame': '2 days after pre-anesthetic visit', 'description': 'Description noted in electronic clinical report form'}, {'measure': 'Global patient satisfaction', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': 'satisfaction on a visual analog scale 0-10'}, {'measure': 'Satisfaction on the delivery of the information', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': '6-item custom questionnaire completed on a Likert 0 - 5 scale for all patients plus 6 questions specific for control group and 7 for intervention group'}, {'measure': 'Ecological impact of the consultation in each group', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': "Carbon impact (CO2 generated) of number of km between the patient's home and the hospital"}, {'measure': 'Economic impact of the consultation in each group', 'timeFrame': 'pre-anesthetic visit = 9 days to 3 months+7 days after inclusion', 'description': 'Cost in euros of cost of travel and time at work missed'}, {'measure': 'Rate of presence of the usual treatment prescription', 'timeFrame': 'During the anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Yes/no'}, {'measure': 'Rate of presence of the completed health questionnaire', 'timeFrame': 'During the anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Yes/no'}, {'measure': 'Rate of presence of specialist consultation reports less than 1 year old', 'timeFrame': 'During the anesthesia consultation = 1 week to 3 months after inclusion', 'description': 'Yes/no'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telemedicine', 'Anesthesia', 'Consultation, Remote']}, 'referencesModule': {'references': [{'pmid': '35877785', 'type': 'RESULT', 'citation': 'Morau E, Blanc A, Boisson C, Sawyers T, Lefrant J, Cuvillon P. Telemedicine for Preanesthesia Consultations During the First COVID-19 Lockdown. Telemed J E Health. 2023 Apr;29(4):621-624. doi: 10.1089/tmj.2022.0143. Epub 2022 Jul 26.'}]}, 'descriptionModule': {'briefSummary': "The anesthesia safety decree made it compulsory in 1994 to carry out a pre-anesthesia consultation before any operative or interventional act. With the inclusion of telemedicine in the Public Health Code then the publication of Addendum 6 in 2018 and finally the derogatory decree in March 2020, it is possible to perform and bill for pre-anesthesia consultation via telemedicine.\n\nThe consultation is always followed by a pre-anesthetic visit upon admission of the patient the day before or the day of the operation to verify the information recorded during the consultation and the patient's state of health. This identifies elements omitted during the pre-anesthesia consultation (face-to-face or remotely) and reduces the risks of potential postponement.\n\nThe study investigators hypothesize that there would be no difference in the quality of the information given, the collection of medical, paramedical and medication elements and the evaluation of the operative risk in anesthesia consultation via teleconsultation versus face-to-face. The critical points are the medication reconciliation of the patient's treatments, the overall assessment of the operative risk and anticipated difficulty of access to the airways (mouth opening: ≥ or \\<35 mmm)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* Patient with scheduled surgical intervention (outpatient or hospitalization) at the Nîmes University Hospital requiring a preoperative anesthesia consultation.\n* Patient with computer equipment at home allowing the use of the Téléo software (computer equipment with web cam, audio and microphone or smartphone).\n\nExclusion Criteria:\n\n* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient who has already had an anesthesia consultation for surgery within the previous 6 months.\n* Emergency or radiology and / or interventional surgery (eg. gastroscopy, biopsy under scanner, etc.).'}, 'identificationModule': {'nctId': 'NCT04920604', 'acronym': 'TELANESTH', 'briefTitle': 'Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.', 'orgStudyIdInfo': {'id': 'NIMAO/2020-2/EM-01'}, 'secondaryIdInfos': [{'id': '2021-A00311-40', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teleconsultation', 'interventionNames': ['Other: Remote anesthesia consultation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: Face-to-face anesthesia consultation']}], 'interventions': [{'name': 'Face-to-face anesthesia consultation', 'type': 'OTHER', 'description': 'The anesthesia consultation is carried out in person in accordance with the usual management.', 'armGroupLabels': ['Control group']}, {'name': 'Remote anesthesia consultation', 'type': 'OTHER', 'description': 'Anesthesia consultation is carried out in teleconsultation via the "Téléo" web application (audio and video) at the patient\'s home on a computer or smartphone. This application allows sending and receiving documents identical to those during the face-to-face consultation.', 'armGroupLabels': ['Teleconsultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Estelle Morau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}