Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT05526534
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pulmonary complication', 'timeFrame': '7 days after the surgery', 'description': 'The primary outcome measures were the incidence of PPC in the treatment group and the control group, including the incidence of postoperative hypoxemia, atelectasis, pneumonia, etc.'}], 'secondaryOutcomes': [{'measure': 'Total Hospitalization days', 'timeFrame': '7 days after the surgery', 'description': 'Postoperative Hospitalization Days and ICU Stay Days'}, {'measure': 'Oxygen therapy', 'timeFrame': '2 days after the surgery', 'description': 'The Need for Oxygen Therapy'}, {'measure': 'Antibiotics', 'timeFrame': '7 days after the surgery', 'description': 'The use of antibiotics, including the type, usage, use time, etc.'}, {'measure': 'Postoperative oxygenation', 'timeFrame': '2 days after the surgery', 'description': 'Improvement of Postoperative Oxygenation'}, {'measure': 'Adverse events', 'timeFrame': '2 days after the surgery', 'description': 'Adverse events Associated with Oxygen Therapy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Surgery', 'High-flow Nasal Cannula', 'Post-operative Pulmonary Complications']}, 'referencesModule': {'references': [{'pmid': '32615190', 'type': 'BACKGROUND', 'citation': 'Chaudhuri D, Granton D, Wang DX, Burns KEA, Helviz Y, Einav S, Trivedi V, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Mbuagbaw L, Hodgson CL, Jaber S, Goligher EC, Brochard L, Rochwerg B. High-Flow Nasal Cannula in the Immediate Postoperative Period: A Systematic Review and Meta-analysis. Chest. 2020 Nov;158(5):1934-1946. doi: 10.1016/j.chest.2020.06.038. Epub 2020 Jun 29.'}, {'pmid': '32157356', 'type': 'BACKGROUND', 'citation': 'Leone M, Einav S, Chiumello D, Constantin JM, De Robertis E, De Abreu MG, Gregoretti C, Jaber S, Maggiore SM, Pelosi P, Sorbello M, Afshari A; Guideline contributors. Noninvasive respiratory support in the hypoxaemic peri-operative/periprocedural patient: a joint ESA/ESICM guideline. Intensive Care Med. 2020 Apr;46(4):697-713. doi: 10.1007/s00134-020-05948-0. Epub 2020 Mar 10.'}, {'pmid': '27771739', 'type': 'BACKGROUND', 'citation': 'Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Patients at high risk of post-operative pulmonary complications (PPC) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the HFNC group and control group, which uses conventional nasal cannula oxygen therapy. The primary outcome is the incidence of PPC, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.', 'detailedDescription': 'This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients With Gynecologic Neoplasms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with gynecologic Neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest CT scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met:\n\n 1. Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points;\n 2. BMI≥30;\n 3. Moderate to severe asthma;\n 4. Moderate to severe chronic obstructive pulmonary disease (COPD);\n 5. Smoking history ≥20 packs/year\n\nExclusion Criteria:\n\n1. Patients with lung metastasis of malignant tumor or primary lung malignant tumor;\n2. previous lung surgery or radiotherapy;\n3. the surgery involved segmental bowel resection.'}, 'identificationModule': {'nctId': 'NCT05526534', 'briefTitle': 'A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan Cancer Hospital and Research Institute'}, 'officialTitle': 'A Randomized Controlled Trial on the Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms', 'orgStudyIdInfo': {'id': 'HFNC202205.V1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFNC group', 'description': 'HFNC group was given heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery to maintain oxygen saturation at 92% \\~ 95%.Chest CT was reviewed 36-48 hours after surgery.', 'interventionNames': ['Device: heated humidified high flow nasal cannula oxygen therapy, HFNC']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'The control group was given conventional nasal catheter oxygen inhalation on the day of surgery and the first day after surgery, and oxygen flow was adjusted to maintain oxygen saturation at 92% \\~ 95%.Chest CT was reviewed 36-48 hours after surgery.', 'interventionNames': ['Device: Nasal cannula oxygen']}], 'interventions': [{'name': 'heated humidified high flow nasal cannula oxygen therapy, HFNC', 'type': 'DEVICE', 'description': 'HFNC can accurately provide 21% \\~ 100% oxygen concentration through air oxygen mixer. And through the heating and humidification device to provide 37℃, relative humidity of 100% gas, the maximum flow of 70L/min.', 'armGroupLabels': ['HFNC group']}, {'name': 'Nasal cannula oxygen', 'type': 'DEVICE', 'description': 'Nasal cannula oxygen has become a routine part of postoperative treatment', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dengfeng Wang, M.D.', 'role': 'CONTACT', 'email': 'wonderful_96@163.com', 'phone': '+86 15982222707'}, {'name': 'Dengfeng Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sichuan Cancer Hospital and Research Institute', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Dengfeng Wang, M.D.', 'role': 'CONTACT', 'email': 'wonderful_96@163.com', 'phone': '+86 159 82222707'}], 'overallOfficials': [{'name': 'Dengfeng Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan Cancer Hospital and Research Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '9 months after the study is published', 'ipdSharing': 'YES', 'description': 'IPD will be available to be shared 9 months after the study is published with a reasonable research plan.', 'accessCriteria': 'Researchers who have a reasonable research plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Dengfeng Wang', 'investigatorAffiliation': 'Sichuan Cancer Hospital and Research Institute'}}}}