Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 1:35 AM
Study NCT ID:
NCT06361693
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive Observational Study of Patient-performed Pre-oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C036166', 'term': 'argipressin, Asu(1,6)-'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FeO2>90%', 'timeFrame': '3 minuts after the beginning of auto-preoxygenation - Day 1', 'description': 'Percentage of patients achieving a FeO2\\>90% in 3 min at 12L/min fresh gas flow on 100% oxygen.\n\nTo Evaluate the efficacity of the self-preoxygenation Assessing the effectiveness of auto-preoxygenation'}], 'secondaryOutcomes': [{'measure': 'APAIS anxiety score', 'timeFrame': 'At arrival in the Day Surgery Unit - Day 1', 'description': 'Percentage of patients with a total APAIS anxiety score greater than 10/20 in women, 12/20 in men on arrival in the operating room'}, {'measure': 'Visual analog anxiety scale (VAS-A) score', 'timeFrame': 'At arrival in the Day Surgery Unit - Day 1', 'description': 'Percentage of patients with a decrease in the visual analog anxiety scale score (VAS-A) between arrival and discharge in the Day Surgery Unit.\n\nAssessing the effect of self-preoxygenation on preoperative anxiety'}, {'measure': 'Visual analog anxiety scale (VAS-A) score', 'timeFrame': 'At discharge from the Day Surgery Unit - Day 1', 'description': 'Percentage of patients with a decrease in the visual analog anxiety scale score (VAS-A) between arrival and discharge in the Day Surgery Unit.\n\nAssessing the effect of self-preoxygenation on preoperative anxiety'}, {'measure': 'Visual analog comfort scale (VAS-C) score', 'timeFrame': 'At discharge from the Day Surgery Unit - Day 1', 'description': 'Percentage of patients having obtained a visual analog comfort scale (VAS-C) score greater than 5 out of 10 upon discharge from the Day Surgery Unit.\n\nAssessing the effect of self-preoxygenation on comfort'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoxygenation', 'General anesthesia', 'Adult', 'Preoperative anxiety'], 'conditions': ['Anesthesia', 'ASA Physical Status I', 'ASA Physical Status II']}, 'descriptionModule': {'briefSummary': 'The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).\n\nThis is the concept of "self-preoxygenation".', 'detailedDescription': 'Pre-oxygenation is a fundamental element of the induction sequence in anesthesia, described and recommended since 1955. Numerous studies have examined and compared the various techniques for implementing this procedure in terms of duration, objectives, equipment, patient characteristics and conditions. None of them specifies who should hold the mask when carrying out this recommendation. In everyday practice, patients are often asked to hold the mask themselves. A preliminary survey showed that 86% of patients are offered this option. The professionals questioned cited relational reasons (83%) above all, but also organizational reasons (43%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major patient (adults) undergoing scheduled outpatient surgery requiring general anesthesia.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient undergoing scheduled surgery with general anesthesia\n* Patient classified ASA I or II\n* Patient understanding and speaking French\n* Patient informed of the study and not opposed to it\n* Decision to have preoxygenation carried out by the patient.\n\nExclusion Criteria:\n\n* Patients with grade II or III obesity (BMI\\>35)\n* Patient with at least one respiratory comorbidity\n* Smoking patient\n* Pregnant patients\n* Patient with an allergy to one of the mask's components\n* Patient with cognitive impairment or known comprehension difficulties\n* Patient under guardianship or curatorship\n* Patient not affiliated to health care system"}, 'identificationModule': {'nctId': 'NCT06361693', 'acronym': 'ApréOx', 'briefTitle': 'Descriptive Observational Study of Patient-performed Pre-oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '"Observational Descriptive Study of Patient-performed Preoxygenation, the "Autopreoxygenation Concept""', 'orgStudyIdInfo': {'id': 'APHP240147'}, 'secondaryIdInfos': [{'id': '2024-A00143-44', 'type': 'OTHER', 'domain': 'France : Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Adult patients benefiting from planned outpatient surgery under general anesthesia.', 'interventionNames': ['Other: Auto-preoxygenation', 'Other: APAIS scale', 'Other: Visual analog anxiety scale (VAS-A)', 'Other: Visual analog comfort scale (VAS-C)']}], 'interventions': [{'name': 'Auto-preoxygenation', 'type': 'OTHER', 'description': 'Management is not modified. Routine monitoring (ECG, BP, SpO2). As in care, the patient takes the mask and the respirator is started, delivering an inspired oxygen fraction of 100% (FiO2=1).\n\nMonitoring of : inspired fraction of oxygen, expired fraction of oxygen and end-tidal fraction of carbon dioxide. The ventilator also provides the respiratory rate and tidal volume carried out by the patient.\n\nThe fresh gas flow is set by default and will be adjusted to 12l/min for patient comfort.After less than a minute, a normal capnia curve and the presence of an FeO2 value appear. Here, time is standardized to 1 min. In the absence of one of these elements, the caregiver always takes control of preoxygenation.Timer is started, it is T0 min. At T 3min, collection of values and decision-making :\n\n* objectives achieved : end of this sequence.\n* objectives not achieved, the caregiver takes control again for an additional 2 minutes in order to seek to achieve an FeO2\\>90%.', 'armGroupLabels': ['Patients']}, {'name': 'APAIS scale', 'type': 'OTHER', 'description': 'APAIS scale', 'armGroupLabels': ['Patients']}, {'name': 'Visual analog anxiety scale (VAS-A)', 'type': 'OTHER', 'description': 'Visual analog anxiety scale (VAS-A)', 'armGroupLabels': ['Patients']}, {'name': 'Visual analog comfort scale (VAS-C)', 'type': 'OTHER', 'description': 'Visual analog comfort scale (VAS-C)', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Sophie TOUSSAINT, Nurse anesthetist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}