Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
Study NCT ID:
NCT04272268
Status:
WITHDRAWN
Last Update Posted:
2024-04-15
First Post:
2020-02-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Covid-19', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of respiratory complications within 30 days after surgery', 'timeFrame': '30 days', 'description': 'including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism.'}], 'secondaryOutcomes': [{'measure': '30 day mortality', 'timeFrame': '30 days'}, {'measure': '90 day mortality', 'timeFrame': '90 days'}, {'measure': '90 day respiratory complication rate', 'timeFrame': '90 days'}, {'measure': 'The proportion of blood gases performed on time', 'timeFrame': '5 days'}, {'measure': 'The proportion of missing results', 'timeFrame': '5 days'}, {'measure': 'Recruitment rate', 'timeFrame': '90 days', 'description': 'To facilitate sample size calculation for such a randomized controlled trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of the Esophagus']}, 'descriptionModule': {'briefSummary': 'The use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied.\n\nNasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. Physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery.\n\nThis study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. The results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.', 'detailedDescription': 'Respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. The primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. Technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. Other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. These data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. The rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. This may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Undergoing Ivor-Lewis (2-stage) oesophagectomy\n* Successfully extubated within 4 hours after surgery\n\nExclusion Criteria:\n\n* History of bullous emphysematous disease\n* Lack of capacity to consent\n* Significant air leak during surgery\n* Incurable disease found at surgery leading to no surgical resection\n* Failure of extubation and spontaneous breathing within 4 hours after surgery'}, 'identificationModule': {'nctId': 'NCT04272268', 'acronym': 'Hi-FLO', 'briefTitle': 'Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals of North Midlands NHS Trust'}, 'officialTitle': 'Evaluating the Feasibility and Safety of Using Nasal High Flow Oxygen for Five Days Postoperatively to Reduce Respiratory Complications After Oesophagectomy for Cancer', 'orgStudyIdInfo': {'id': '2063'}, 'secondaryIdInfos': [{'id': '214643', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nasal High flow Oxygen', 'description': 'Following consent, the participant will undergo Oesophagectomy as per routine care. During surgery, prior to trial participation and as per standard of care at the site, a nasogastric tube will be placed into the gastric conduit and secured to the nose. This tube will be left on free drainage and aspirated every 4 hours to check for inadvertent insufflation.', 'interventionNames': ['Device: Nasal High flow Oxygen']}], 'interventions': [{'name': 'Nasal High flow Oxygen', 'type': 'DEVICE', 'description': 'If the patient is successfully extubated within 4 hours following surgery and meets the post surgery inclusion/exclusion criteria, Nasal high flow oxygen will be administered continuously using a humidifier machine for 5 days. Breathing circuits and nasal cannulae will be connected to the machine to deliver oxygen at 20L/min to the patient.', 'armGroupLabels': ['Nasal High flow Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ST44JJ', 'city': 'Stoke-on-Trent', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'Robert James Bowler', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Gerorge Bouras', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of North Midlands NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals of North Midlands NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}